Regulatory Focus™ > News Articles > Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

Posted 10 April 2012 | By Alexander Gaffney, RAC 

The medical device industry is being shaken by a series of issues involving St. Jude Medical's defibrillator leads, reports The New York Times, leading to serious questions about transparency, adequate regulation and patient safety.

The medical device leads have been implicated in a series of serious adverse events, including some where the wire contained inside the defibrillator leads have failed, leaving the wires to become exposed.

The Times reports two other medical device companies have experienced similar issues to St. Jude in 2005, including the heart unit of Guidant, which was sold to Boston Scientific in 2006, and Medtronic.

"For the heart device industry, the problem with the [leads] is the third highly visible safety episode in the last seven years," notes TheTimes. "As such, it is raising questions about whether the industry is adequately scrutinizing the safety of heart devices or whether the Food and Drug Administration (FDA) needs to take a more aggressive role."

"Several heart device experts said that the St. Jude incident represented a troubling repeat performance," said The Times. "As with Guidant and Medtronic, the crucial data highlighting the problems with St. Jude's leads did not come from its own monitoring systems, but from outside researchers."

St. Jude is responding aggressively to the charges, calling for the recall of an outside study it maintains is error-prone and flawed while maintaining the company is adequately transparent about its actions.

The company is also calling attention to the voluntary adverse event reporting system, saying its submissions were highly detailed and thus look worse in comparison to competitors using sparser reporting data.

The New York Times - Troubling Flaws in a Heart Device Shake Implant Makers

WSJ - FDA in Hot Seat on Safety

MedPage Today - Device Maker Wants Study Retracted


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