HAVE YOU BEEN INJURED BY A MEDTRONIC PAIN PUMP?
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 DESIGN DEFECTS
The SynchroMed II has been linked to two serious problems:
- Pocket fills– A design defect which 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, resurgence of symptoms, and life-threatening drug withdrawal.
MEDTRONIC HALTS MANUFACTURING OF PAIN PUMP
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.
PAST FDA WARNINGS AND MEDTRONIC PUMP RECALLS
- July 2009 — Medtronic sends a letter to physicians warning about potential battery problems which could cause the SynchroMed II to fail.
- January 2011 — Medtronic sends an urgent letter warning health care professionals about a defect which could lead to “pocket fills” during device refills.
- February 2011 — The FDA issues a Class I recall on Medtronic SynchroMed II Infusion Pumps due to the design defect which causes “pocket fills.”
- July 2011 — FDA issues a Class I Recall on SynchroMed II Infusion Pumps due to battery issues originally warned against in 2009.
CONTACT AN EXPERIENCED DEFECTIVE MEDICAL DEVICE LAWYER
If you or a loved one have been injured by a dangerous SynchroMed pain pump, contact Thomas J. Henry. For more than a decade, Medtronic’s SynchroMed II pain pump has been subjected to multiple recalls and the company has been under scrutiny for failing to address important safety issues. Complications from a malfunctioning pain pump can include respiratory distress, overdose, withdrawals, coma, and in some cases death. You may be entitled to compensation if you were harmed by a defective medical device like the SynchroMed II pain pump. Contact us today for a free legal consultation and speak to one of our experienced medical device attorneys — available 24/7, nights and weekends.