Williams Kherkher Petitions FDA to Inspect Medtronic Facilities

Today, Williams Kherkher petitioned the FDA to conduct in-depth inspections of all Medtronic facilities where the Sprint Fidelis Leads were designed, manufactured, sterilized and packaged. Some 204,000 U. S. citizens were implanted with the recalled Sprint Fidelis Leads between September 2004 and October 15, 2007 -- the date of the recall. About 166,500 individuals still have the defective lead implanted in their chest. For those with Sprint Fidelis Leads still implanted, Medtronic's statistics indicate about 10,000 will fail this year, resulting in a series of life-threatening shocks or, in a few cases, death.

According to documents received under the Freedom of Information Act, the FDA has so far conducted only cursory inspections of some of the facilities involved in the Fidelis Lead debacle. Williams Kherkher is petitioning the FDA to conduct inspections of all facilities at a level appropriate to the magnitude of the health risk caused by the recall of the Sprint Fidelis Leads.

Williams Kherkher will keep you informed of the FDA's response.

A complete copy of the petition filed today is available by clicking here.