For Immediate Release
Media Contact: Bob Cooper
(208) 334-4112
Date: August 30, 2007
Wasden Urges Patients with Implanted Defibrillators to Make Safety Check with Doctor
(Boise) – A legal settlement with the maker of an implantable heart defibrillator will make available up to one million dollars in compensation for consumers, Attorney General Lawrence Wasden said today.
Wasden urged Idahoans with an implanted defibrillator to contact the doctor who implanted the device to determine if it is the make and model with potential safety defects. The settlement, and related safety concerns, applies only to “unmodified” Ventak Prizm 2 DR Model 1861. The defibrillator is manufactured by Guidant Corporation, a wholly owned subsidiary of Boston Scientific.
Implantable defibrillators are medical devices that doctors surgically implant in a patient’s chest to monitor for abnormal heart rhythms. If the heart stops, the device delivers a small electric shock to start the heart functioning again.
To correct a Prizm wiring problem that could cause the unit to short circuit, Guidant made changes to the Prizm in 2002. If a short circuit occurred, the Prizm could fail to deliver a life-saving shock to a patient’s heart when needed. However, Guidant continued to sell unmodified Prizms, even after making two separate changes to correct the wiring problem. Guidant did not inform physicians or the public until May 2005 that it had continued to sell unmodified Prizms in 2002 and 2003.
Currently, Guidant is conducting a warranty program to provide consumers who wish to replace their Prizms with a new device at no cost and to reimburse consumers up to $2,500 for out-of-pocket expenses they incur with this replacement. Pursuant to today’s settlement, Guidant has extended this warranty program for an additional six months. Also, the States will use up to $1,000,000 of the settlement fund to reimburse warranty program participants for expenses they incurred beyond $2,500. Detailed information regarding the claims process will be posted on Attorney General Wasden’s website when it becomes available.
Pursuant to the settlement, Guidant agreed to implement implantable defibrillator safety programs, publicly report important safety information about the potentially life-saving heart devices it manufactures and pay $16,750,000 to the states. Guidant does not admit to any wrongdoing.
Guidant also agreed to:
- Establish a patient safety advisory board consisting of independent experts to evaluate data concerning implantable defibrillator performance;
- Establish a patient safety officer position, staffed by a physician whose primary responsibility is to advance implantable defibrillator patient safety;
- Clearly disclose and disseminate to the public specific information on a quarterly basis, including worldwide failure data, survival probability estimates and current information in the event of an FDA recall of any implantable defibrillator;
- Post a notice on its website within 30 days of any modification to any of its implantable defibrillators to correct a failure pattern;
- Solicit the return of out-of-service implantable defibrillators; and
- Maintain a data system to track the serial numbers, implant dates and explant dates of all implantable defibrillators Guidant distributes in the United States.
The State of Idaho will receive $390,000 as its portion of the settlement.
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