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MEDICAL DEVICE RECALL
Canadian physicians who implant cardiac defibrillators are calling on Guidant Corporation and other manufacturers to notify doctors and patients as soon as device failures occur.
"All of this information has to be provided to the stakeholders in a timely way, and there has to be complete openness and transparency," says Dr. Chris Simpson, president of the Canadian Heart Rhythm Society and director of the arrhythmia service at Kingston General Hospital.
In Canada, 962 people were affected this spring and summer by Guidant Canada's recall of several models of implantable cardiac defibrillators (ICDs), which was triggered by a frontpage New York Times story saying the company had concealed problems with one model for 3 years. (For a chronology see www.cmaj.ca/cgi/content/full/173 /8/855/DC1)
Guidant also recalled several pacemaker models because seals were prone to gradual deterioration, potentially depleting the device's batteries; 1622 Canadians were affected by that recall.
The Times began to investigate the ICDs when 21-year-old Joshua Oukrop died of cardiac arrhythmia in March after the Guidant Ventak Prizm 2 DR 1861 he had implanted in 2001 failed to shock his heart back into rhythm. A subsequent analysis of the device revealed that it had short-circuited - a problem Guidant told Oukrop's doctors that it knew about but was not planning to tell doctors and patients. The physicians then went to the Times.
Although Guidant detected the problem in 2002 and fixed subsequent models, it continued to sell those manufactured before 2002 and did...