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U.S. Department of Health and Human Services

Class 1 Device Recall SynchroMed II Implantable Infusion Pump

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 Class 1 Recall
SynchroMed II Implantable Infusion Pump
see related information
Date Posted June 25, 2013
Recall Status1 Open
Recall Number Z-1570-2013
Recall Event ID 65135
Premarket Approval
PMA Number
P860004/S056
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
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.
Code Information all SynchroMed II pumps
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Consumer Instructions No consumer action necessary
For Additional Information Contact Technical Services
800-707-0933
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 261,109 total devices estimated implanted Worldwide
Distribution Worldwide Distribution - USA Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LKK and Applicant = MEDTRONIC VASCULAR
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