Model 8637 SynchroMed II Implantable Drug Infusion Pump Product Performance and Advisories

2017

Urgent: Medical Device Correction Update - April 2017 Battery Performance of the Model 8637 SynchroMed® II Implantable Drug Infusion Pump

Update to the 2011 Notification

Models Affected:
8637-20, 8637-40

Description:
This clinician communication 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.

Reduced battery performance impacts battery voltage, which can prematurely activate the pump Elective Replacement Indicator (ERI), End of Service (EOS), and/or cause a Low Battery Reset.

pdf SynchroMed II Battery HCP Letter (April 2017) (.pdf)

183KB

pdf Alarm Information Sheet (.pdf)

30KB

pdf Pump Event Information (.pdf)

108KB

SynchroMed II Serial Number Lookup
This link leads to a web-based tool that can be used to determine the pump manufacture timeframe based on pump serial number.