Defibrillator Maker Reaches Safety Settlement
Posted August 30, 2007 12:43 p.m. EDT
Raleigh, N.C. — One of the country's largest manufacturers of implantable cardioverter defibrillators (ICD) has reached a settlement over safety claims.
Guidant will pay out $16.7 million to 36 states, including North Carolina. They will also disclose all safety information about ICDs, extend warranties and help patients pay to replace one type of ICD it manufactures, the Ventak Prizm 2 DR Model 1861.
"Patients with heart problems rely on these devices," said state Attorney General Roy Cooper. "We want to make sure this life-saving tool is as safe as possible, and that patients and doctors get the information they need about any safety problems."
Through its warranty program, Guidant is currently providing consumers with a new ICD at no cost and reimbursing patients up to $2,500 for out-of-pocket costs related to the replacement.
As part of Thursday's settlement, Guidant has agreed to extend this warranty program for an additional six months and will pay up to $1,000,000 to the states to help patients who have their Prizm replaced cover any additional costs that are not covered by the $2,500 payment.