Recalls / —
—#118941
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 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 implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:
- 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 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
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 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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- worldwide
Timeline
- Recall initiated
- 2013-06-03
- Posted by FDA
- 2013-06-25
- Terminated
- 2015-11-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #118941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.