Medtronic 8637-20 Reference Guide

Important Labeling Updates Related to Priming Bolus
with the SynchroMed

Information about the priming bolus function is found in the following SynchroMed® II
Infusion System manuals:

®

II Infusion System

■ SynchroMed® and IsoMed® Implantable Infusion Systems Information for
Prescribers Manual

■ Model 8637 SynchroMed® II Programmable Pump Implant Manual

■ Model 8840 N'Vision® Clinician Programmer with Model 8870 Software for

SynchroMed® II Infusion Systems Programmer Guide

The updated manual content provides important safety information regarding priming
bolus, patient management and monitoring recommendations, and procedural instructions.

Note: The intent of this reference booklet is to direct you to the updated manual content. It is not a

substitute for the full instruction in the manuals.

Important Safety Information

A warning related to priming bolus is in the information for prescribers manual on pages
9 – 10 and the clinician programmer manual on pages 54 – 55.

Warnings

Priming bolus (SynchroMed Pumps) - Mixing of drug and non-drug (sterile

water/CSF) fluids occurs at the high flow rates used during a priming bolus. This
mixing can result in patients receiving drug prior to the end of the priming bolus, as
well as a period of reduced drug concentration following the priming bolus, and can
lead to adverse events involving drug overdose, underdose, and withdrawal. These
adverse events will vary depending on the drug being infused, and could include
lack of therapeutic effectiveness, confusion or altered mental state, sleepiness,
nausea, respiratory depression, coma or death. Refer to "Emergency Procedures"
in the indications, drug stability, and emergency procedures manual and the
appropriate drug labeling for specific drug underdose and overdose symptoms and
actions. Follow these guidelines regarding priming bolus:

■ Use the priming bolus procedure to ensure that therapy is initiated while the patient
is under medical supervision.

■ To reduce the risk of overdose during a priming bolus, consider priming the pump
before connecting the catheter to the pump (back table prime) during an initial
system implant or a pump replacement. Refer to the clinician programmer guide
for information on how to program the priming bolus.

■ For a full system priming bolus: Avoid high concentration drug solutions with a low
total daily dose as the risk for overdose and underdose can be more pronounced.

Reference booklet 2017-12-31 English 1

■ For a full system priming bolus: Priming bolus default parameters have been
carefully selected based on extensive modeling and testing. To ensure optimal
initiation of therapy, modifications to these values are not recommended.

■ For a full system priming bolus: Based on the therapeutic index of the drug and the
sensitivity of the patient, some individuals may need additional monitoring until the
delivered drug reaches the intended concentration. Do not increase the
programmed daily dose within the first 48 hours following a priming bolus as the
delivered drug may not have reached the intended concentration during this time.

■ Medtronic recommends monitoring patients after any priming bolus procedure
involving intrathecal therapy.

– Opioids: Patients should be monitored with pulse oximetry for a minimum of

24 hours in a facility equipped with emergency airway management, oxygen,
naloxone for treatment of opioid overdose and other emergency services.

– Baclofen: Patients should be monitored in a facility that provides experienced

nursing observation, with the ability and personnel for emergency airway
management and ventilator support readily available. Patients should be
monitored for a minimum of 8 hours or until they demonstrate stable
neurological, respiratory and cardiac function.

– Ziconotide: There are no labeling guidelines for patient monitoring after

starting or restarting ziconotide therapy. Published guidance recommends an
overnight admission.

■ Educate caregivers and family members to recognize the signs and symptoms
associated with intrathecal drug overdose, underdose, and withdrawal. Instruct
them to contact the patient's physician if they notice any of these signs or
symptoms and to seek emergency assistance as necessary.

The following patient populations were identified as having increased risk of
adverse events from drug overdose and underdose:

■ Elderly patients.

■ Patients with compromised respiratory, renal, hepatic, or cardiac function.

■ Patients exposed to other agents, such as systemic opioids, alcohol, sedatives,

antihistaminics, or psychotropic drugs, that can potentiate the central nervous
system depressant effects of intrathecal morphine.

■ Opioid-naïve or opioid-sensitive patients undergoing new pump and catheter
implants, especially those prescribed high concentration drug solutions with low
daily doses.

■ Patients who are sensitive to baclofen and require low daily doses.

■ For baclofen patients undergoing pump or catheter revision, a delay in achieving

the intended therapeutic dose could occur and may result in temporary return of
symptoms such as increased spasticity or baclofen withdrawal.

Note: Other clinically relevant patient populations may exist in addition to these
examples.

2 English 2017-12-31 Reference booklet