Sept 10, 2011 - Medtronic 8637 SynchroMed II Infusion Pump Recall
Sept 10, 2011
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall -
Potential for Reduced Battery Performance
AUDIENCE: Hospital Risk Manager
ISSUE: Medtronic and FDA notified healthcare professionals of a Class I recall
of the SynchroMed II Infusion system. Medtronic’s analysis of the problem
indicates it is related to the formation of a film within the pump battery. This
problem can lead to the sudden loss of therapy and the return of underlying
symptoms and/or therapy withdrawal symptoms.
The recall includes the SynchroMed II Implantable Infusion Pump models 8637-20
and 8637-40, distributed between May 2004 and July 8, 2011.
BACKGROUND: The SynchroMed II Implantable Programmable Drug Pump is part of the
SynchroMed II Infusion system designed to contain and administer prescribed
drugs to a specific site. This infusion pump is indicated to deliver morphine
sulfate, ziconotide and baclofen for the treatment of chronic pain, severe
chronic pain and severe spasticity, respectively. It is also indicated for
delivery of floxuridine and methotrexate for the treatment of primary or
metastatic cancer.
RECOMMENDATION: Medtronic encourages patients to carry their patient
identification cards with them at all times and to contact their physicians
immediately if they experience a return of symptoms or hear a device alarm.
Healthcare professionals and patients are encouraged to report adverse events or
side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete
and return to the address on the pre-addressed form, or submit by fax to
1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I Recall Notice,
at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm271510.htm