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The Medtronic SynchroMed II is a drug infusion pump, commonly known as a pain pump, which delivers pain medication directly into the spinal fluid.
Approved by the Food and Drug Administration (FDA) in 2004, the surgically implanted device is inserted under the patient’s skin and is used to treat patients with cancer, muscle spasms, or chronic pain.
Since its approval, the Medtronic SynchroMed II has been mired with problems, many of which have resulted in serious complications. Since 2009, design defects in the SynchroMed II have led to accidental overdoses, underdoses, life-threatening withdrawals, and patient deaths.
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.