Medtronic Neuromodulation: Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.

Recall number

Z-1570-2013

Recalling firm

Medtronic Neuromodulation

Product

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer.

Status

Terminated

Initiated

2013-06-03

Posted

2013-06-25

Terminated

2015-05-14

Reason

Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.

Root cause

Device Design

Action

Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the background and nature of the issue and provided recommendations for patient management and monitoring after initiation of Intrathecal Therapy. The letter directed customers to continue to use the priming bolus precedure; to monitor all patients following start or restart of intrathecal therapy; consider priming the pump prior to implant; and educate caregivers and family members to recognize the signs and sypmtoms associated with intrathecal drug therapy complications. For questions contact your local Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Quantity

261,109 total devices estimated implanted Worldwide

Distribution

Worldwide Distribution - USA Nationwide

Lot, serial or model codes

all SynchroMed II pumps

510(k) numbers

not on file

PMA numbers

["P860004S056"]

Product code

LKK

Firm FEI

2182207

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy