Medtronic 8637 User Manual

SynchroMed® II

Programmable pumps

Implant manual

  Rx only

8637

2003

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not reuse

Do not resterilize

2

STERILIZE

Do not use if package is damaged

Sterilized using ethylene oxide

-XX °C

-XX °F

EO

Consult instructions for use

Use by

Date of manufacture

Manufacturer

XX °C

Temperature limitation

XXX °F

Keep away from magnets

Serial number

STERILE

Conformité Européenne (European Conformity). This symbol means
that the device fully complies with AIMD Directive 90/385/EEC (NB

0123).

For USA audiences only

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EC

Authorized representative in the European community

REP

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Medtronic® and SynchroMed® are trademarks of Medtronic, Inc., registered in the U.S. and
other countries.

®

Prialt

is a registered trademark of Azur Pharma International Limited.

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Table of contents

Description 9

Package contents 10

Patient identification card 10

Device specifications 11

Device longevity 14

Flow rate accuracy 15

Measurement error 15
Fluid volume 15
Environmental conditions 16

Declaration of Conformity 18

Instructions for use 19

Preparing for pump implant 19
Sterile procedure 20
Emptying the pump 20
Preparing to fill the pump 21
Filling the pump 21
Priming the pump before implant (if applicable) 22
Replacing an implanted pump 22
Preparing the pump pocket 23

Refer to the indications, drug stability, and emergency procedures reference
manual for indications and related information.

Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment,
patient selection, use in specific populations, and component disposal.

Refer to the appropriate drug labeling for indications, contraindications, warnings,
precautions, dosage and administration information, and screening procedures.

! USA

Refer to the clinical summary booklet for information on the clinical study

results of the infusion system and adverse events summary.

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Implanting the pump 23
Programming the pump 24
Updating the patient record 26
Monitoring the patient 26
Refilling the pump or accessing the catheter access port 26

Technical support 27

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Description

The implantable Medtronic Model 8637 SynchroMed II programmable pump is part of an
infusion system that stores and delivers a prescribed drug to a specific site. The implanted
infusion system consists of a Model 8637 SynchroMed II pump and a catheter.

The catheter connects to the pump catheter port. The pump is anchored in the pump pocket
using the suture loops on the outside of the pump (Figure 1).

Reservoir fill port

Figure 1. Pump exterior view.

The drug is stored in the pump reservoir (Figure 2). Per a programmed prescription, the
drug moves from the pump reservoir, through the internal pump tubing, catheter port, and
catheter, to the infusion site. The catheter access port (CAP) allows injection of drug
directly into the implanted catheter for drug administration and diagnostic purposes. Drug
injected into the CAP bypasses the pump mechanism and goes directly through the
catheter port into the implanted catheter to the infusion site. The CAP allows entry of a 24­gauge noncoring needle to prevent accidental injection during refill procedures (which use
the 22-gauge noncoring needle supplied in the refill kit).

The manufacturer and model code recorded on a radiopaque identifier are visible using
standard x-ray procedures.

Suture loop

Catheter access port

Catheter port

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