Medtronic Synchromed II Lawsuit Alleges Problems Caused Pump to Overdeliver Medication

A Pennsylvania man has filed a product liability lawsuit alleging that problems with a Medtronic Synchromed II infusion pump caused him to receive an over-delivery of pain medication, resulting in severe and permanent injuries.

The complaint (PDF) was filed last month by Jason Silver in the U.S. District Court for the Middle District of Pennsylvania, alleging that the Medtronic Synchromed II was defectively designed and prone to malfunctions that may cause serious medication problems.

Silver had a Medtronic Synchromed II pump implanted in his abdomen in December 2012, for treatment of chronic pain linked to cervical radiculopathy and cervicalgia. The pump was supposed to deliver controlled levels of pain medications into the intrathecal space of his spine. However, in the summer of 2014, the Synchromed pump malfunctioned and overdelivered medication, causing severe pain, nausea and a lack of mobility that required hospitalization.

The Medtronic SynchroMed II Infusion Pump line has been plagued with problems over the last several of years, which have caused many users to suffer severe and potentially life-threatening health issues.

In February 2011, the FDA declared a Class I Medtronic Synchromed pump recall following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.

In September 2011, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. The FDA classified that as a Class I recall as well. Class I medical device recall classifications mean that the FDA believes the device has a reasonable likelihood of causing severe injury or death.

In July 2012, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.

The FDA finally entered into a consent decree with Medtronic over the repeated errors and manufacturing problems in April 2015, which required the company to cease manufacturing, designing and distribution of new Medtronic Syncromed II infusion pumps, except in cases where a doctor determined it was medically necessary for a patient’s treatment.

In addition to the halt of manufacturing, Medtronic must also retain a third-party expert to help develop plans to correct the violations. The consent decree will remain in effect until the FDA is satisfied that all of the Medtronic Synchromed problems have been addressed.

“Throughout the history of the manufacture of the SynchroMed II Device, Medtronic has shown an indifference to federal manufacturing requirements,” Silver’s lawsuit states. “Further, Medtronic, with full knowledge that they were manufacturing the SynchroMed II Device in violation of the law, nonetheless demonstrated a pattern of delayed responses or complete failures to respond to reported and known safety issues with the SynchroMed II Device.”

Silver presents claims of defective manufacturing, failure to warn, negligence, breach of warranty, negligent misrepresentation, and violation of Pennsylvania unfair trade practices and consumer protection laws. He is seeking both compensatory and punitive damages.