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.

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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.

Image Credit: Image via Ken Wolter / Shutterstock.com

4 Comments

  • brendaJanuary 10, 2020 at 9:53 pm

    IN 2018 Sept 19th Medtronic was installed. Dec.03 2018 severe hallucinations began several days later I died. I was revived and spent two months in the hospital because of the hallucinations and heart. Life is now not worth living. I am sick at my stomach constantly. I am very weak and my memory has been affected. Prialt was used in the pump to relieve pain and I feel Prialt is a drug straight out[Show More]IN 2018 Sept 19th Medtronic was installed. Dec.03 2018 severe hallucinations began several days later I died. I was revived and spent two months in the hospital because of the hallucinations and heart. Life is now not worth living. I am sick at my stomach constantly. I am very weak and my memory has been affected. Prialt was used in the pump to relieve pain and I feel Prialt is a drug straight out of Hell. Please don't have this drug put in your body.

  • MarkOctober 3, 2017 at 9:16 am

    I have one of these pumps and four weeks ago it malfunctioned and gave me too much morphine which caused a cardiac arrest. I live in Australia and am keen to find out if anyone else in Australia has had same problem or similar. Also what lawyer did they use.

  • SethJune 22, 2017 at 2:39 am

    Have my second SynchroMed2 now. Worst decision I ever made. New neuro-degeneration symptoms are staggering. Letting it empty (safely) and getting it out before it paralyzes me.

  • NicoleMarch 13, 2017 at 4:14 pm

    My husband passed away last year. He had a Medtronic intra the call Synchromed pain pump. It over infused on two occasions in 4 months.

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