The New York Times, "Guidant to Issue More Data on Device Failures"

          The Guidant Corporation, a maker of defibrillators and pacemakers, said yesterday that it planned to start issuing periodic reports that would highlight for each model the number of confirmed failures that prevented the units from delivering critical patient therapy.
          The move appears to be a significant change because Guidant, like other makers of heart devices, had previously told doctors only about the total number of product malfunctions, rather than separating those that posed high risks from those of lesser concern.
          A Guidant spokesman, Steven Tragash, would not say how soon the company planned to start regularly releasing more detailed product failure information to doctors.
          Because of a lack of data on specific models, doctors may not be aware that a particular model may be malfunctioning in a way that could harm patients or even contribute to their deaths, several device specialists have said.
          Guidant, which is based in Indianapolis, has been criticized for failing to disclose to doctors a high-risk defect - the tendency of two devices, a defibrillator and an advanced pacemaker, to short-circuit. Four deaths have been associated with the electrical failures of the devices.
          Earlier this week, Guidant disclosed that it had received a subpoena from the United States attorney's office in Minneapolis seeking information about the devices. Guidant did not elaborate on the type of information sought.
          A defibrillator is a device that sends out an electrical charge to interrupt a potentially fatal heart rhythm; a pacemaker is a device that regulates a heart that is beating too fast or too slowly.
          Guidant's policy change on physician reporting was noted in a broader company report that was sent last month to the Food and Drug Administration in response to concerns raised by the agency after an inspection of a manufacturing plant.