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CAPSURE Z
Steroid eluting, bipolar, implantable, tined, atrial, transvenous lead
®
NOVUS 5554
Technical Manual
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
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The following are trademarks of Medtronic:
CapSure, CapSure Z, Medtronic
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Contents
1 Description 3
2 Indications 3
3 Contraindications 3
4 Warnings and precautions 3
5 Potential complications 4
6 Implant procedure 5
7 Specifications (nominal) 9
8 Medtronic warranty 9
9 Service 9
1 Description
The Medtronic CapSure Z Novus Model 5554 steroid eluting,
bipolar, implantable, tined, atrial, transvenous lead features
a tip electrode with a hemispherical microporous surface
composed of platinum that has been coated with the steroid
dexamethasone sodium phosphate. The ring electrode is
composed of platinum alloy.
The tip electrode contains a maximum of 1.0 mg of
dexamethasone sodium phosphate, a portion of which is in
a silicone rubber binder. Upon exposure to body fluids, the
steroid elutes from the electrode. The lead is designed to
provide low chronic pacing thresholds via steroid treatment
of cardiac tissue near the lead tip. Steroid suppresses the
inflammatory response that is believed to cause threshold
rises typically associated with implanted pacing electrodes.
The distal portion of the lead is J-shaped. This facilitates
placement of the electrode in or near the apex of the right
atrial appendage.
The lead size is reduced from current Medtronic bipolar leads
due to a change in the silicone insulation material. This
correlates to a smaller lead body. These leads use a 7 French
introducer or a 9 French introducer with guide wire.
The lead also features four polyurethane tines near the
electrode tip, MP35N nickel alloy conductors, silicone rubber
insulation, and an IS-1 Bipolar (BI)
1.1 Package contents
Leads and accessories are supplied sterile. Each package
contains the following items:
1 lead with anchoring sleeve, stylet, and stylet guide
•
1 vein lifter
•
extra stylets
•
product literature
•
1
IS-1 BI refers to an International Connector Standard (ISO 5841-3)
whereby pulse generators and leads so designated are assured
of a basic mechanical fit.
1
lead connector.
1.2 Accessory descriptions
Anchoring sleeve – An anchoring sleeve secures the lead to
prevent it from moving and protects the lead insulation and
conductors from damage caused by tight sutures.
Stylet – A stylet provides additional stiffness and controlled
flexibility for maneuvering the lead into position. Each stylet
knob is labeled with the stylet diameter and length.
Stylet guide – A stylet guide facilitates stylet insertion into
the lead.
Vein lifter – A vein lifter facilitates lead insertion into a vein.
2 Indications
The Model 5554 lead is designed to be used with a pulse
generator as part of a cardiac pacing system. The lead has
application where implantable atrial, single chamber or dual
chamber pacing systems are indicated.
3 Contraindications
Use of atrial tined transvenous leads may be
•
contraindicated in the absence of a right atrial appendage.
Use of steroid eluting transvenous leads is
•
contraindicated in patients for whom a single dose of
1.0 mg dexamethasone sodium phosphate may be
contraindicated.
4 Warnings and precautions
Line-powered and battery-powered equipment – An
implanted lead forms a direct current path to the myocardium.
During lead implant and testing, use only battery-powered
equipment or line-powered equipment specifically designed for
this purpose to protect against fibrillation that may be caused
by alternating currents. Line-powered equipment used in
the vicinity of the patient must be properly grounded. Lead
connector pins must be insulated from any leakage currents
that may arise from line-powered equipment.
Diathermy – People with metal implants such as
pacemakers, implantable cardioverter defibrillators (ICDs), and
accompanying leads should not receive diathermy treatment.
The interaction between the implant and diathermy can
cause tissue damage, fibrillation, or damage to the device
components, which could result in serious injury, loss of
therapy, and/or the need to reprogram or replace the device.
Vessel and tissue damage – Use care when positioning the
lead. Avoid known infarcted or thin ventricular wall areas to
minimize the occurrence of perforation and dissection.
Single use – The lead is for single use only.
Inspecting the sterile package – Inspect the sterile package
with care before opening it.
Contact a Medtronic representative if the seal or package
•
is damaged.
Do not store this product above 40 C˚ (104 F˚).
•
Do not use the product after its expiration date.
•
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Ethylene oxide resterilization – The lead has been sterilized
with ethylene oxide before shipment. If the sterile package
seal is broken before the lead’s expiration date, resterilize
using only a validated ethylene oxide resterilization process.
The lead should not be autoclaved or sterilized by gamma
radiation and should not be cleaned in ultrasonic cleaners.
Refer to sterilizer instructions for operating instructions.
•
Place the lead in an ethylene oxide permeable package
•
before resterilization.
Do not exceed temperatures of 55 C˚ (131 F˚).
•
Do not resterilize more than one time.
•
Use an acceptable method to determine sterilizer
•
effectiveness, such as biological indicators.
Allow the lead to aerate ethylene oxide residues before
•
implant and after resterilization.
Steroid use – It has not been determined whether the
warnings, precautions, or complications usually associated
with injectable dexamethasone sodium phosphate apply to
the use of this highly localized, controlled-release lead. For a
list of potential adverse effects, refer to the Physicians’ Desk
Reference.
Handling the steroid tip – Avoid reducing the amount of
steroid available before implanting the lead. Reducing the
available amount of steroid may adversely affect low-threshold
performance.
Do not allow the electrode surface to come in contact with
•
surface contaminants.
Do not wipe or immerse the electrode in fluid, except
•
blood, at the time of implant.
Handling a tined lead – Handle the lead with care at all times.
Do not implant the lead if it is damaged. Return the lead to
•
a Medtronic representative.
Protect the lead from materials that shed small particles
•
such as lint and dust. Lead insulators attract these
particles.
Handle the lead with sterile surgical gloves that have been
•
rinsed in sterile water or a comparable substance.
Do not severely bend, kink, or stretch the lead.
•
Do not immerse the lead in mineral oil, silicone oil, or any
•
other liquid, except blood, at the time of implant.
Do not use surgical instruments to grasp the lead.
•
Do not force the lead if resistance is encountered during
•
lead passage.
Handling the stylet – Handle the stylet with care at all times.
Curve the stylet before inserting it into the lead to achieve
•
a curvature at the lead’s distal end. Do not use a sharp
object to impart a curve to the distal end of the stylet.
Do not use excessive force or surgical instruments when
•
inserting the stylet into the lead.
Avoid overbending or kinking the stylet.
•
Use a new stylet when blood or other fluids accumulate on
•
the stylet. Accumulated blood or other fluids may damage
the lead or cause difficulty in passing the stylet into the
lead.
Necessary hospital equipment – Keep external defibrillation
equipment nearby for immediate use during acute lead system
testing, the implant procedure, or whenever arrhythmias are
possible or intentionally induced during post-implant testing.
Concurrent devices – Output pulses, especially from unipolar
devices, may adversely affect device sensing capabilities.
If a patient requires a separate stimulation device, either
permanent or temporary, allow enough space between the
leads of the separate systems to avoid interference in the
sensing capabilities of the devices. Previously implanted pulse
generators and implantable cardioverter defibrillators should
generally be explanted.
Chronic repositioning or removal of a tined lead – Proceed
with extreme caution if a lead must be removed or repositioned.
Chronic repositioning or removal of tined transvenous leads
may be difficult because of fibrotic tissue development on the
lead. In most clinical situations, it is preferable to abandon
unused leads in place. Return all removed leads, unused
leads, or lead sections to Medtronic for analysis.
Lead removal may result in avulsion of the endocardium,
•
valve, or vein.
Lead junctions may separate, leaving the lead tip and bare
•
wire in the heart or vein.
Chronic repositioning of a lead may adversely affect a
•
steroid lead’s low-threshold performance.
An abandoned lead should be capped so that the lead
•
does not transmit electrical signals.
Severed leads should have the remaining lead end sealed
•
and the lead body sutured to adjacent tissue.
5 Potential complications
The potential complications (listed in alphabetical order)
related to the use of transvenous leads include, but are not
limited to, the following patient-related conditions that can
occur when the lead is being inserted or repositioned:
cardiac perforation
•
cardiac tamponade
•
fibrillation and other arrhythmias
•
heart wall rupture
•
infection
•
muscle or nerve stimulation
•
pericardial rub
•
pneumothorax
•
thrombolytic and air embolism
•
thrombosis
•
valve damage (particularly in fragile hearts)
•
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Other potential complications related to the tined lead and the
programmed parameters include, but are not limited to, the
complications listed in the following table. Symptoms of the
following potential complications include loss of capture or
intermittent or continuous loss of capture or sensing
Complication
Lead dislodgement Reposition the lead.
Lead conductor fracture or
insulation failure
Threshold elevation or exit block Adjust the implantable device
Corrective action to be
considered
Replace the lead. In some
cases with a bipolar lead,
the implantable device may
be programmed to a unipolar
configuration or the lead may be
unipolarized.
output. Replace or reposition
the lead.
2
:
Potential acute or chronic complications associated with tined
lead placement that may require lead replacement to correct
include, but are not limited to, the following:
Implant technique Potential complication
Forcing the lead through the
introducer
Use of too medial of an approach
with venous introducer resulting
in clavicle and first rib binding
Puncturing the periosteum
and/or tendon when using
subclavian introducer approach
Advancing the lead into the
venous insertion site and/or
through the veins without the
stylet fully inserted
Electrode damage, tine damage,
insulation damage
Conductor coil fracture,
insulation damage
Conductor coil fracture,
insulation damage
Tip distortion, insulation
perforation
6 Implant procedure
Proper surgical procedures and sterile techniques are the
responsibility of the medical professional. Some implant
techniques vary according to physician preference and the
patient’s anatomy or physical condition.
6.1 Using a stylet guide and stylets
Caution: To avoid lead tip distortion, keep the stylet fully
inserted into the lead during lead introduction and while
advancing the lead. Keeping the stylet fully inserted into the
lead is especially important while navigating through tortuous
veins that may cause the stylet to “back out” of the lead.
Caution: To avoid damage to the stylet, do not use a sharp
object to impart a curve to the distal end of a stylet (Figure 1).
2
Transient loss of capture or sensing may occur for a shor t time
following surgery until lead stabilization takes place. If stabilization
does not occur, lead dislodgement may be suspected.
The lead is packaged with the stylet guide attached to the
connector pin and a stylet already inserted into the lead. If the
stylet guide has been removed, replace it by gently pushing it
as far as possible onto the connector pin (Figure 2).
Figure 1.
Use the stylet guide to inser t a stylet into the lead. If a slight
curve is needed for the stylet, use only a smooth object to
impart a curve to the distal portion of a stylet (Figure 1).
Figure 2.
6.2 Selecting an insertion site
Caution: When using a subclavian approach, insert the lead
using a more lateral approach to minimize the risk of first rib
clavicular crush. First rib clavicular crush may subsequently
fracture the lead body.
Caution: Certain anatomical abnormalities, such as thoracic
outlet syndrome, may pinch and subsequently fracture the
lead body.
The lead may be inserted by venotomy through several
different venous routes, including the right or left cephalic
vein, other subclavian branches, or the external or internal
jugular vein. The lead may also be inser ted into a subclavian
vein through a percutaneous lead introducer (PLI). Select the
desired entry site (Figure 3).
Note: If wiping the lead is necessary before insertion, ensure
that the anchoring sleeve remains in position.
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Figure 3.
1
1 Suggested entry site
6.3 Using the vein lifter
Caution: Use care when handling the lead during inser tion.
Avoid placing the lead under extreme tension or angulation to
prevent possible lead fracture. Avoid gripping the lead with
surgical instruments.
Use the vein lifter:
1. Inser t the tapered end of the vein lifter into the incised
vein (Figure 4).
Figure 4.
2. Gently push the lead tip underneath the vein lifter and into
the vein.
6.4 Positioning a tined atrial J-shaped lead
Note: For improved maneuverability through the vein, insert
a straight stylet into the lead to straighten the J-portion of the
lead.
Position a tined atrial J-shaped lead:
1. Advance the lead into the right atrium.
2. Use fluoroscopy to facilitate accurate lead placement.
3. Position the lead tip in the right atrium just above the
tricuspid valve.
4. Withdraw the stylet partially so that the lead assumes its
natural J-shape.
5. Maneuver the lead using fluoroscopy so that the tip faces
forward (anterior) and slightly to the patient’s left until the
tip enters and becomes lodged in the atrial appendage.
Note: At this point, further retraction of the lead will cause
the J-portion to open.
6. Check the position of the lead’s distal tip by twisting
the lead body at the vein entry site approximately one
clockwise turn and then one counterclockwise turn.
7. Use fluoroscopy to ensure that the J-portion of the lead is
moving back and forth while the electrode remains stable.
Note: If the lead tip changes position or flops back and
forth, it is likely that the electrode is not properly lodged
into the atrial appendage.
8. Adjust the lead tension so that the J-portion is snug during
maximal exhalation and opens to almost an L-shape
during deep inhalation.
Accurate positioning and wedging of the electrode are
essential for stable pacing and sensing. Generally, a
satisfactory position has the lead tip situated against the atrial
endocardium in or near the apex of the appendage. As viewed
on fluoroscopy (A-P view), the lead tip points medially and
forward toward the left atrium (Figure 5). A lateral view will
show the opening of the J-portion facing the patient’s sternum.
Figure 5.
If properly positioned, the lead tip will sway from side to side
with each atrial contraction (viewed under A-P fluoroscopy). In
the absence of spontaneous atrial activity, movement can be
produced by pacing the atrium through the lead.
6.5 Taking electrical measurements
Take electrical measurements:
1. Attach the clip of a surgical cable to the notch on the stylet
guide (Figure 6).
Figure 6.
Note: A unipolar lead requires the use of an indifferent
electrode.
2. Use an implant support instrument to obtain electrical
measurements. Medtronic recommends using a pacing
system analyzer. For information on the use of the implant
support instrument, see the product literature for that
device.
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Satisfactory lead placement is indicated by low stimulation
thresholds and adequate sensing of intracardiac signal
amplitudes.
A low stimulation threshold provides for a desirable
•
safety margin, allowing for a possible rise in thresholds
that may occur within 2 months following implant.
Adequate sensing amplitudes ensure that the lead is
•
properly sensing intrinsic cardiac signals. Minimum
signal requirements depend on the device’s sensitivity
capabilities. Acceptable acute signal amplitudes for the
lead must be greater than the minimum device sensing
capabilities, including an adequate safety margin to
account for lead maturity.
Tab le 1 . Recommended measurements at implant
Measurement required Ventricle Atrium
Maximum acute stimulation thresholds
Minimum acute sensing amplitudes 5.0 mV 2.0 mV
a
At pulse duration setting of 0.5 ms.
3. If electrical measurements do not stabilize to acceptable
levels, repositioning the lead and repeating the testing
procedure may be necessary.
Note: Initial electrical measurements may deviate from
the recommendations because of acute cellular trauma. If
such a deviation occurs, wait 5 to 15 minutes and repeat
the testing procedure. Values may vary depending upon
lead type, device settings, cardiac tissue condition, and
drug interactions.
6.5.1 Checking diaphragmatic stimulation for tined leads
Diaphragmatic stimulation should also be checked by pacing
at 10 V and a pulse width setting greater than 0.5 ms and
observing for diaphragmatic contracting either by fluoroscopy
or direct abdominal palpitation. This should be checked
for both atrial and ventricular leads. Further testing may
include patient positional changes to simulate upright chronic
conditions.
If diaphragmatic pacing occurs, reduce the voltage until
a diaphragmatic pacing threshold is determined. A
diaphragmatic threshold of 5 to 6 V or less usually necessitates
repositioning of the lead.
6.5.2 Taking pacing impedance (or resistance) measurements
Pacing impedance (or resistance) is used to assess device
function and lead integrity during routine device patient
follow-up and to assist in troubleshooting suspected lead
failures. Additional troubleshooting procedures include ECG
analysis, visual inspection, measurement of thresholds, and
electrogram characteristics.
a
1.0 V
3.0 mA
1.5 V
4.5 mA
Pacing impedance values are affected by many factors
including lead position, electrode size, conductor design
and integrity, insulation integrity, and the patient’s electrolyte
balance. Apparent pacing impedance is also significantly
affected by the measurement technique. Comparison of
pacing impedance should be done using consistent methods
of measurements and equipment.
An impedance higher or lower than the typical values is
not necessarily a conclusive indication of a lead failure.
Other causes must be considered as well. Before reaching
a conclusive diagnosis, the full clinical picture must be
considered. The full clinical picture includes pacing artifact
size and morphology changes in 12-lead analog ECGs,
muscle stimulation with bipolar leads, sensing and/or capture
problems, patient symptoms, and device characteristics.
Recommendations for clinically monitoring and evaluating
leads in terms of impedance characteristics are listed below.
Consider the following recommendations for devices with
telemetry readout of impedance:
Routinely monitor and record impedance values at implant
•
and follow-ups using consistent output settings.
Note: Impedance values may be different at different
programmable output settings (for example, pulse width or
pulse amplitude) of the device or pacing system analyzer.
Establish a baseline chronic impedance value once the
•
impedance has stabilized, generally within 6 to 12 months
after implant.
Monitor for significant impedance changes and abnormal
•
values.
Where impedance abnormalities occur, closely monitor
•
the patient for indications of pacing and sensing problems.
The output settings used for measuring impedance should
be the same as those used for the original measurements.
For patients at high risk, such as implantable
•
device-dependent patients, physicians may want to
consider further action such as increased frequency of
monitoring, provocative maneuvers, and ambulatory ECG
monitoring.
Consider the following recommendations for devices without
telemetry:
Record impedance value at implant. Also record
•
the measurement device, its output settings, and the
procedure used.
At the time of device replacement, if pacing system
•
analyzer-measured impedance is abnormal, carefully
evaluate lead integrity (including thresholds and physical
appearance) and patient condition before electing to reuse
the lead.
Impedances below 250
•
current drain, which may seriously compromise device
longevity, regardless of lead integrity.
For more information on obtaining electrical measurements,
consult the product literature supplied with the testing device.
may result in excessive battery
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6.6 Anchoring the lead
Cautions:
Use care when anchoring the lead.
•
Use an anchoring sleeve with all leads.
•
Do not use absorbable sutures to anchor the lead.
•
Do not secure the sutures so tightly that they damage the
•
vein, lead, or anchoring sleeve.
Do not use the anchoring sleeve tabs for suturing
•
(Figure 7).
Do not tie a suture directly to the lead body (Figure 8).
•
Do not dislodge the lead tip.
•
Do not attempt to remove or cut the anchoring sleeve.
•
Do not remove the tabs on anchoring sleeves. Tabs are
•
provided to minimize the possibility of the sleeve entering
the vein.
If using a large diameter percutaneous lead introducer
•
(PLI) sheath, extreme care should be taken to prevent
passage of the anchoring sleeve into the PLI lumen or the
venous system.
Figure 7.
1
1 Anchoring sleeve tab
Figure 8.
With a triple groove anchoring sleeve, generally 2 or 3 of the
grooves may be used with the following procedure.
Anchor the lead:
1. Position the anchoring sleeve close to the lead’s connector
pin to prevent inadvertent passage of the sleeve into the
vein.
2. Inser t the anchoring sleeve partially into the vein.
3. Use the most distal suture groove to secure the anchoring
sleeve to the vein.
4. Use the middle groove to secure the anchoring sleeve to
the fascia and lead (Figure 9):
a. Create a base by looping a suture through the fascia
underneath the middle groove and tying a knot.
b. Firmly wrap the suture around the middle groove and
tie a second knot.
Figure 9.
5. If anchoring with all three grooves, use the third and most
proximal groove to secure the anchoring sleeve to the lead
body (Figure 10).
Figure 10.
6.7 Connecting the lead
Caution: Always remove the stylet and stylet guide before
connecting the lead to the device. Failure to remove the stylet
and stylet guide may result in lead failure.
Connect the lead to the device according to the instructions in
the product literature supplied with the device.
Connect the lead to the device:
1. Carefully and completely remove the stylet and stylet
guide.
Note: When removing the stylet and stylet guide, firmly
grip the lead just below the connector pin to help prevent
possible lead dislodgement.
2. Obtain final electrical measurements.
3. Inser t the lead connector into the connector block on the
device. For instructions on proper lead connections, see
the product literature supplied with the device.
6.8 Placing the device and lead into the pocket
Cautions:
Use care when placing the device and lead into the pocket.
•
Ensure that the lead does not leave the device at an acute
•
angle.
Do not grip the lead or device with surgical instruments.
•
Do not coil the lead (Figure 11). Coiling the lead can twist
•
the lead body and may result in lead dislodgement.
Figure 11.
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Caution: To prevent undesirable twisting of the lead body,
wrap the excess lead length loosely under the device and place
both the device and the lead into the subcutaneous pocket.
Place the device and lead into the pocket:
1. Rotate the device to loosely wrap the excess lead length
under the device (Figure 12).
Figure 12.
Parameter Model 5554
Bipolar: 51 (53 cm)
Tip to ring
spacing
Steroid Dexamethasone sodium
Amount of steroid 1.0 mg maximum
Steroid binder Silicone rubber
17 mm
phosphate
8 Medtronic warranty
For complete warranty information, see the accompanying
warranty document.
2. Inser t the device and lead into the pocket.
3. Suture the pocket closed.
4. Monitor the patient’s electrocardiogram until the patient is
discharged. If a lead dislodges, it usually occurs during
the immediate postoperative period.
7 Specifications (nominal)
Parameter Model 5554
Type Bipolar
Chamber Atrium
Fixation 4 tines, each 2.5 mm in length
Length
Connector IS-1 BI
Material Conductor: MP35N nickel alloy
Connector
Connector
Insulator: Silicone rubber
electrode:
electrode:
Tip electrode configuration Hemispherical, platinized,
Diameters Lead body:
electrode:
electrode:
Lead introducer (recommended size)
without guide
with guide
Electrode surface
area
Resistance Unipolar: 37 (53 cm)
20–110 cm
Stainless steel
pin:
Stainless steel
ring:
Ring
Polished platinum alloy
Tip
Platinum
Tines: Polyurethane
porous, steroid eluting
2.0 mm
2.1 mm
Ring
1.0 mm
Tip
7 French (2.3 mm)
wire:
9 French (3.0 mm)
wire:
Ring:
Tip:
36 mm
1.2 mm
2
2
9 Service
Medtronic employs highly trained representatives and
engineers located throughout the world to serve you and, upon
request, to provide training to qualified hospital personnel in
the use of Medtronic products. Medtronic also maintains a
professional staff to provide technical consultation to product
users. For medical consultation, Medtronic can often refer
product users to outside medical consultants with appropriate
expertise. For more information, contact your local Medtronic
representative, or call or write Medtronic at the appropriate
address or telephone number listed on the back cover.
9
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World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.Medtronic.com
Tel. 763-514-4000
Fax 763-514-4879
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical consultation for
physicians and medical professionals)
Bradycardia: 1-800-505-4636
Tachycardia: 1-800-723-4636
Heart Failure: 1-800-505-4636
Europe/Africa/Middle East Headquarters
Medtronic Europe Sàrl
Route du Molliau 31
Case Postale
CH-1131 Tolochenaz
Switzerland
Internet: www.Medtronic.co.uk
Tel. 41-21-802-7000
Fax 41-21-802-7900
Medtronic E.C. Authorized Representative/
Distributed by
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-45-566-8000
Fax 31-45-566-8668
Asia
Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay, Hong Kong
Tel. 852-2891-4068
Fax 852-2591-0313
Australia
Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road
Gladesville NSW 2111
Australia
Tel. 61-2-9879-5999
Fax 61-2-9879-5100
Canada
Medtronic of Canada Ltd.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Tel. 905-826-6020
Fax 905-826-6620
Toll-free in Canada: 1-800-268-5346
Japan
Medtronic Japan
Solid Square West Tower 6F,
580 Horikawa-cho, Saiwai-ku
Kawasaki, Kanagawa 210-0913
Japan
Tel. 81-44-540-6112
Fax 81-44-540-6200
Technical manuals:
www.Medtronic.com/manuals
© Medtronic, Inc. 2005
A03381001B
2005-11-02
*A03381001*
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