Problems continue to plague Medtronic, the world’s largest standalone medical device manufacturer and technology development company, after its SynchroMed II drug infusion pump has been linked to more than a dozen deaths and other serious adverse events.
The SynchroMed II is an implantable infusion system designed to deliver drugs in a manner tailored to the precise needs of each individual patient, distributing medication directly into the intrathecal space surrounding the spinal canal. The device consists of a pump (which is roughly the size of a hockey puck) and a thin flexible catheter (tubing). The pump is implanted under the patient’s skin in the lower abdomen. The catheter carries the medication from the pump to the spinal canal. A reservoir in the pump contains the medication and a computer controls its rate of flow. The system allows clinicians to adjust the dose of pain medication or chemotherapy drugs in a noninvasive manner.
Close to 250,000 SynchroMed II devices have been implanted in patients battling severe spasticity, chronic pain, and advanced metastatic cancer.
Medtronic recently admitted that two more patients have died as a result of dosing errors in the infusion system manufactured by the company’s neuromodulation division in Columbia Heights, Minnesota. The device has been associated with a number of deaths and other serious adverse events due to:
- Over-infusion or overdosing (delivery of too much medication)
- Electrical shorting in the pump’s internal circuit causing motor stalls (leading to abrupt cessation of therapy)
- Motor stalls followed by sudden restart (leading to unusually high, near-lethal doses)
- Defective batteries resulting in pump failure
- Depletion of the pump’s reservoir without the warning alarm going off (leading to withdrawal symptoms)
- Problems with the device leading doctors to inject the drug near the pump rather than into the pump
- Misalignment between the delivery tube and the pump
- Memory failure leading to multiple complications
In 2013, after the SynchroMed II infusion system had been linked to 14 deaths, the FDA issued a Class I recall notice. Medtronic was forced to sign a consent decree in 2015 after it repeatedly failed to correct violations and meet federal manufacturing standards. Regulators in the United Kingdom, Canada, and Hong Kong have also issued serious warnings about the SynchroMed II drug infusion pump.
Currently, the FDA consent decree prohibits Medtronic from widespread distribution of the device, limiting its use to extraordinary circumstances when a treating physician certifies its medical necessity. For its part, the company continues to counsel doctors on the best way to use the pump and avoid problems, while admitting to the allegations and promising to take necessary steps to rectify them. But even as Medtronic tries to remedy the problems that plague the SynchroMed II pump, there is rising concern that the device needs to come off the market completely.
The Medtronic SynchroMed II is just one example of the serious injuries that can occur from defective medical devices. If you have had complications from the use of a SynchroMed II pump or another medical device, please contact the attorneys in Sommers Schwartz’s Personal Injury Litigation Group today to discuss your situation.