Medtronic’s Cardiac Leads & FDA Safety

Article in the Wall Street Journal — Medtronic and FDA Face Scrutiny on Safety Issues, by Anna Wilde Mathews and Thomas M. Burton.  Here’s an excerpt:

Medtronic Inc.’s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of how safety concerns about them were handled by the company and the Food and Drug Administration.

Plaintiffs attorneys, a consumer group and Iowa Sen. Chuck Grassley are examining the history of the Sprint Fidelis leads, which are electrical wires that connect the hearts of patients to the defibrillators implanted in their chests.

On Monday, Minneapolis-based Medtronic disclosed that the Sprint Fidelis wires have fractured in about 2.3% of the 268,000 models made, 235,000 of which are still implanted in people. The company said the fractures may have contributed to five deaths.

In early signs of the pressure likely to come for Medtronic and the FDA, Mr. Grassley, a Republican, last night sent letters to the company and the agency asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner.

BGS