The New York Times, "Repeated Defect in Heart Devices Exposes a History of Problems"

          Two months after Joshua Oukrop's death, the Guidant Corporation, the country's second-biggest maker of heart defibrillators, acknowledged that it had not told doctors for three years that one model had short-circuited in about two dozen cases, including the one involving him.
          Guidant, which has said it did nothing wrong, has characterized the student's death as a tragic event. But it turns out that the same type of electrical defect that destroyed Mr. Oukrop's defibrillator also caused another heart device from Guidant to malfunction.
          Short circuits involving that device, an advanced pacemaker that also contains a defibrillator, have been associated with the deaths of three patients. Guidant said recently that it was aware of 49 short-circuit reports involving both devices, out of a total of 42,000 units produced, a malfunction rate that the company has characterized as low.
          The devices' problems may be linked to Guidant's use of an insulating material that in some cases can deteriorate if exposed to moisture like body fluids.
          Another device maker, Medtronic Inc., said it had stopped using the material, called polyimide, in the 1990's when it changed how all its devices were made. Another company, St. Jude Medical, said it used polyimide only inside the sealed part of its heart devices, where the material was shielded from moisture.
          Executives of Guidant, who declined to be interviewed for this article, have said the company made all required reports to the FDA about the devices, including malfunction reports. The agency is investigating the company; FDA criminal investigators are involved in the inquiry.