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Potential Medtronic Infusion Pump Malfunction Claims: Resource4thePeople Attorneys Now Providing Consulations
Date:10/21/2013

s on its bone-growth product InFuse. The studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments. Medtronic, which describes itself as 'the world's largest independent medical technology company,' also maintained significant, previously-undisclosed financial ties with physicians who authored studies about InFuse, making $210 million in payments to physicians over a 15-year period."

In a press release*** issued as part of the FDA Class 1 Recall Notice involving the SynchroMed Pumps, Medtronic officials provided additional details about the shorting problem:

"Medtronic has issued an Urgent Medical Device Correction notification to inform physicians about the potential for an electrical short within the SynchroMed pump. The FDA has classified this notification as a Class I recall.

"An electrical short could lead to pump motor stall and a subsequent loss of or reduction in therapy, which can result in the return of underlying symptoms and/or withdrawal symptoms. The SynchroMed II pump is equipped with alarms designed to alert the patient in the event of a motor stall.

"Medtronic encourages patients to contact their physicians immediately if they experience a return of symptoms or hear a device alarm. The cumulative failure rate due to this issue is less than one percent at seven years post implant. Because of the estimated low occurrence rate, the alarm safety feature and the risks associated with replacement surgery, Medtronic is not recommending removal of the devices unless a patient's pump shows signs of a malfunction. Medtronic is in the process of developing design updates to mitigate this issue."

Medtronic also provided the following details of how the devices are used:

"Physicians implant the devices in recipients’ lower abdomens underneath the skin, with one end of a catheter ins
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