Ashcraft & Gerel is representing patients harmed by the defective Medtronic Synchromed II implantable drug infusion pump.
The Synchromed II pump is designed to deliver medication (such as baclofen or pain drugs) directly into the spinal fluid to treat severe chronic pain and spasticity. However, the device has been plagued by numerous FDA Class I recalls and safety issues, including:
- Motor stalls and premature battery failure
- Pocket fills during refills (unintended drug injection into tissue)
- Over- or under-delivery of medication
- Catheter problems and alarm failures
These defects have been linked to serious complications such as drug withdrawal syndrome, return of severe symptoms, respiratory distress, overdose, hospitalization, and even death.
Medtronic has faced multiple FDA actions, including a 2015 consent decree that halted new production in many cases, and the company previously established a multimillion-dollar settlement fund for affected patients.
