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SynchroMed II - Programmable Pump
- Starting date:
- April 27, 2017
- Posting date:
- May 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63236
Reason
This notice provides an update to information previously communicated to physicians in July 2011 regarding the failure rate for reduced battery performance in Medtronic Model 8637 SynchroMed II pumps manufactured through June 2011. This notice reinforces previously communicated patient management recommendations related to this issue. This notification does not apply to SynchroMed II devices currently being marketed or implanted, or to any previously implanted devices manufactured after June 2011. Medtronic previously issued a notification regarding the potential for sudden loss of therapy due to reduced battery performance from the formation of a resistive film in a small percentage of SynchroMed II pumps with batteries manufactured prior to July 2011. Performance monitoring of the affected pump population has since found a higher-than-predicted failure rate in a subset of affected pumps manufactured between January 2011 and June 2011.
Affected products
SynchroMed II - Programmable Pump
Lot or serial number
Contact manufacturer
Model or catalog number
8637-20
8637-40
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES