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:
Enforcement
- Recall Number
- Z-1579-2013
- Event ID
- 65443
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Neuromodulation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- July 3, 2013
- Initiation Date
- June 3, 2013
- Classification Date
- June 25, 2013
- Termination Date
- November 16, 2015
- Address
- 7000 Central Ave NE, Minneapolis, MN, 55432-3568, United States
Description
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:
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
all SynchroMed II pumps
worldwide
261,109 total devices estimated implanted Worldwide