Medtronic Pain Pump Recall Considered Class I

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Medtronic Pain Pump Recall Considered Class I

September 29th, 2008 laurie

The FDA has officially classified as a recall a safety alert involving an implantable drug pump that Medtronic Inc. had issued in June. One patient has died, and 83 patients have experienced improper connections between implanted catheters and pumps that deliver infused drugs.

The improper connections can result in leaks of pain drugs that can cause fatal overdoses, withdrawal symptoms or the return of symptoms the medication is supposed to treat, Medtronic said.

The pumps are used in patients who have spasticity related to cystic fibrosis, traumatic brain injury and multiple sclerosis and from chronic pain. About 25,000 of the catheters have been sold since May 2007, according to Medtronic.

However, neither the FDA nor the company requires that the pump be removed from patients. The company recommended that doctors monitor patients who have the recalled products and that patients and their caregivers be aware of a possible drug overdose or withdrawal.

The affected models of the pump include: Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.

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