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U.S. Department of Health and Human Services

Class 1 Device Recall SynchroMed EL Implantable Infusion Pump

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 Class 1 Recall
SynchroMed EL Implantable Infusion Pump
see related information
Date Posted June 25, 2013
Recall Status1 Open
Recall Number Z-1580-2013
Recall Event ID 65443
Premarket Approval
PMA Number
P860004/S042
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
Product Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids:
Code Information all SynchroMed EL pumps
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Technical Services
800-707-0933
Manufacturer Reason
for Recall
Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und
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 issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933. For questions regarding this recall call 763-526-9738.
Quantity in Commerce 261,109 total devices estimated implanted Worldwide
Distribution worldwide
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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