Personal Injury Law

Medtronic Issues Another Class I FDA Recall

A little over a week has passed since the medical device manufacturer Medtronic issued its Class 1 Recall for its automated external defibrillators (AEDs), this AED recall following a number of dangerous Medtronic medical device recalls Tennessee Law Blog has reported. Now news has broken of yet another dangerous medical device Medtronic manufactured and the FDA considers life-threatening: Sutureless Intrathecal Catheters.

These sutureless connector intrathecal catheters (also called SC catheters) are part of implantable drug infusion systems for administering drugs to the spine, and their defectiveness makes these Medtronic infusion systems unsafe and dangerous medical devices. The affected Medtronic models are

INDURA 1P Intrathecal Catheter, Model 8709SC

Intrathecal Catheter, Model 8731SC

Sutureless Pump Connector Revision Kit, Model 8578

Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC

Over 25,000 of these SC catheter pumps are being used by patients since the came on market in May 2007. Most patients who use the SC catheter pumps have constant spasms from traumatic brain injury, multiple sclerosis, or other causes and need the steady supply of heavy medication these SC infusion pumps deliver.

In June, Medtronic told FDA and doctors worldwide that it had reports of problems with its infusion pumps--83 reports to be exact. The Medtronic SC catheters subject to recall clogged or came loose from the pump, which in both cases makes it difficult to deliver the necessary, sometimes vital, medications these defective medical devices were designed to deliver.

Symptoms of the defective Medtronic medical device include overdose and withdrawal symptoms in the patient. For those patients receiving intrathecal baclofen therapy, symptoms can include death, as baclofen withdrawal leads to life-threatening conditions if not cared for properly. This was the case for the one confirmed death attributed to a defective SC catheter pump.

The recalled Medtronic intrathecal drug delivery systems use pump implanted in the intrathecal space in the spine, which is the area around the spinal cord. Powerful drugs (e.g. baclofen, morphine, and ziconotide) are administered here to make them even more power as they can enter the spinal fluid without crossing the blood-brain barrier and go directly to the brain.

If your Tennessee loved one was injured by a malfunctioning Medtronic Intrathecal Catheter Pump, the Nashville law offices of Higgins, Himmelberg & Piliponis wants to help. Call (615) 353-0930 or fill out our Tennessee medical device injury attorney form for a free initial consultation with a defective medical device lawyer.

Full post as published by Tennessee Law Blog on September 29, 2008 (boomark / email).