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Cara feiler
3 years ago
Ventak Prizm 2 DR Model 1861 implantable defibrillator tagged in patient death. May 25, 2005: Guidant Corp. reports 26 cases of failure, including the death of a young Minnesotan — from its Ventak Prizm 2 DR Model 1861 implantable defibrillator. The advisory coincides with a New York Times article saying the company waited years to warn […]
Ventak Prizm 2 DR Model 1861 implantable defibrillator tagged in patient death. May 25, 2005: Guidant Corp. reports 26 cases of failure, including the death of a young Minnesotan — from its Ventak Prizm 2 DR Model 1861 implantable defibrillator. The advisory coincides with a New York Times article saying the company waited years to warn physicians about problems with Guidant defibrillators.
June 17: Guidant voluntarily issues a worldwide safety advisory for seven types of defibrillators.
June 24: Guidant issues a second worldwide safety advisory, warning doctors to discontinue use of five models of defibrillators.
July 1: The Food and Drug Administration classifies Guidant’s safety advisories as recalls.
July 18: Guidant warns doctors that nine pacemaker models made between 1997 and 2000 may need to be replaced.
July 22: Guidant says a programming change it had recommended to fix flaws in some defibrillators actually increased the chances of malfunctions in three models.
Aug. 1: The FDA approves the relaunch of Guidant’s top-selling defibrillator, the Contak Renewal 3.
Sept. 22: Guidant issues recalls or safety advisories for nearly 170,000 of its top-selling Insignia and Nexus pacemakers. It notifies doctors the failure rate for two defibrillators — the Contak Renewal and Contak Renewal 2 — was nearly triple what it had earlier estimated.
Sept. 29: Citing sources it did not name, the New York Times reports the FDA has started a criminal investigation of Guidant.
Oct. 25: U.S. attorney’s offices in Boston and Minneapolis issue subpoenas to Guidant, Fridley-based Medtronic and Little Canada-based St. Jude Medical for an inquiry into possible violations of “anti-kickback” and “false claims” statutes and whether doctors and clinics received inducements to use the devices.
Nov. 3: New York Attorney General Eliot Spitzer sues Guidant, alleging the company concealed information about a design flaw in a defibrillator.
Jan. 24, 2006: The U.S. attorney’s office in Minneapolis subpoenas Guidant for records disclosed in a Texas lawsuit that indicate the company knew that some heart devices could catastrophically fail.
Feb. 23: FDA inspectors cite Guidant’s Arden Hills plant for failing to correct quality problems and belatedly notifying regulators about a design change in implantable defibrillators.
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