—#117981

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.

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004S056
Affected lot / code info: all SynchroMed II pumps

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide

Timeline

Recall initiated: 2013-06-03
Posted by FDA: 2013-06-25
Terminated: 2015-05-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.