Canada just issued an urgent warning about <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">SynchromedÂ® II Drug Infusion Pumps due to the potential for reduced battery operation. Health Canada released the urgent medical device correction because the battery performance of the Model 8637 SynchromedÂ® II Implantable Drug Infusion Pump could fail, leading to a sudden loss of therapy. This urgent warning is an update to a 2009 communication.
In a letter written by Medtronic and released by Health Canada, the device maker stated that on July 13, 2009, Medtronic sent a Medical Device Correction letter to healthcare professionals about the potential for reduced battery performance in some Medtronic Model 8637 SynchroMedÂ® II pumps and to advise, among other issues, that the letter was re-emphasizing previously communicated patient management recommendations. Medtronic indicated that it was not pulling the SynchroMed II pump from the field or recommending prophylactic replacement of the defective devices.
The reduction in battery performance was caused by formation of a resistive film within the SynchroMed II pump battery. Reduced battery performance may result in a Low Battery Reset (critical alarm), premature Elective Replacement Indicator (non-critical alarm), or the premature End of Service (critical alarm). For affected pumps, the minimum timeframe of 90 days between Elective Replacement Indicator and End of Service may also be reduced. The letter included a description of Low Battery Reset, Elective Replacement Indicator, and End of Service, as well as screenshots showing how the Medtronic N’VisionÂ® Model 8840 clinician programmer displays these events. The document can be accessed via the expanded Health Canada release at: http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/synchromed_infusion_hpc-cps-eng.php
A patient treated with a pump that exhibits reduced battery performance may experience either return of his/her underlying symptoms and/or withdrawal symptoms. Of particular note, patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not promptly and effectively treated.
As a matter-of-fact, one patient death was attributed to this issue and baclofen withdrawal syndrome was deemed the culprit. Patients with pumps experiencing Low Battery Reset or premature Elective Replacement Indicator due to this issue will require surgical revision to replace or remove their pump. Meanwhile, as of May 31, 2011, 55 cases have been confirmed worldwide. Review of the returned pumpsâ€”which are meant to last up to 84 monthsâ€”indicated that alarms were functioning as designed.
Medtronic Technical Services can be reached, toll-free, at 1.800.707.0933 to determine if an Elective Replacement Indicator message can be considered premature. Medronic also recommended a number of actions including to increase the critical alarm frequency to improve the probability of early identification of a Low Battery Reset (critical alarm) condition and changing the critical alarm interval frequency to sound every 10 minutes. Other recommendations and an Alarm Information sheet are included in the expanded Health Canada release.