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