BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT CORP

    MDR report key: 432434 · Received December 9, 2002

    Report

    Report Number
    MW1026954
    Event Type
    Injury
    Date Received
    December 9, 2002
    Date of Event
    March 28, 2002
    Report Date
    December 2, 2002
    Manufacturer
    GUIDANT CORP., CARDIAC RHYTHM MFG GROUP
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PACEMAKER/DEFIBRILLATOR MADE BY GUIDANT CORP. WAS IMPLANTED IN PT'S CHEST. ON THE DATE OF THE FIRST PERIODIC CHECK-UP, DATA FROM THE PACEMAKER SHOWED THAT ONE LEAD HAD FAILED 30 TO 60 DAYS EARLIER. SUBSEQUENT COMPARATIVE X-RAYS SHOWED NO LEAD MOVEMENT; THE LEAD HAD SIMPLY FAILED. RPTR WAS IMMEDIATELY ADMITTED TO THE HOSP AND THE FAILED LEAD AS WELL AS THE OTHER LEAD WERE REPLACED THE NEXT MORNING. THIS LEAD WAS DEFECTIVE, AND FAILED IN ONLY 30 TO 45 DAYS. THE SUPPLYING COMPANY, GUIDANT, AGREED TO COVER "SOME" OF THE REPLACEMENT COSTS. TO DATE, THEY HAD DONE NOTHING. THE BILL FOR THE REPLACEMENT SURGERY TOTALS TENS OF THOUSANDS OF DOLLARS, WHICH THEY ATTEMPTED TO PLACE ON MEDICARE (PT HAD NOT AUTHORIZED) AND/OR PRIVATE INSURANCE, WHICH PT HAD INSTRUCTED NOT TO PAY THE BILL. GUIDANT HAS CONSISTENTLY SUPPLIED DEFECTIVE EQUIPMENT, AS EVIDENCED BY THEIR FAILURE ANALYSIS REPORTS, AND HAVE DONE SO WITH IMPUNITY. REPORTER ASK IF THE FDA SHOULDN'T HOLD THEM RESPONSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT CORP AICD HEART PACEMAKER LWS GUIDANT CORP., CARDIAC RHYTHM MFG GROUP 1861 *
    2 GUIDANT CORP. LEAD LWS GUIDANT CORP., CARDIAC RHYTHM MFG GROUP 0155 *
    3 GUIDANT CORP LEAD LWS GUIDANT CORP., CARDIAC RHYTHM MFG GROUP 1488TC *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L