Medtronic Synchromed II linked to serious design flaws
The SynchroMed II has been linked to two serious problems:
- Pocket fills– A design defect that can cause the pain medication to be injected into the area under the patient’s skin during refills (instead of into the device itself). “Pocket fills” can lead to overdose and patient death.
- Battery failures– In some implants, a film develops in the battery compartment that can reduce battery performance and lead to underdosing, the resurgence of symptoms, and life-threatening drug withdrawal.
In April 2015, the FDA and Medtronic came to an agreement after Medtronic repeatedly failed to correct violations over a seven-year period between 2006 and 2013. Multiple inspections of Medtronic’s Minnesota Neuromodulation facility turned up a host of violations regarding complaint handling and corrective actions. Due to the failure to correct the violations on several occasions, Medtronic will not be allowed to manufacture and distribute their SynchroMed II pain pump until they are permitted by the FDA.
Unfortunately, the recalled pain pump was linked to 14 deaths and more than 100 other adverse events, according to Medtronic.