BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 8517898 · Received March 24, 2006

    Report

    Report Number
    2124215-2006-99362
    Event Type
    Death
    Date Received
    March 24, 2006
    Date of Event
    December 5, 2002
    Report Date
    July 26, 2007
    Product Code
    LWS
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO "GUIDANT FOR ANALYSIS. GUIDANT WILL CONTINUE TO INVESTIGATE THE COMPLAINT, AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE REOPENED. IN JUNE, 2005, GUIDANT ISSUED A PHYSICIAN COMMUNICATION REGARDING A DETERIORATION IN WIRE INSULATION WITHIN THE LEAD CONNECTOR BLOCK THAT MAY, WITH OTHER FACTORS, RESULT IN AN ELECTRICAL SHORT CIRCUIT. GUIDANT ALSO ISSUED AN ADVISORY UPDATE ON DECEMBER 21, 2005 WITH ADDITIONAL INFORMATION RELATED TO THIS ISSUE. MANUFACTURING CHANGES TO PREVENT THIS FAILURE WERE MADE IN APRIL AND NOVEMBER OF 2002. THIS DEVICE WAS MANUFACTURED BEFORE APRIL, 2002, AND IS INCLUDED IN THIS POPULATION. WHILE THIS DEVICE WAS PART OF THE ADVISORY POPULATION, GUIDANT DOES NOT HAVE SUFFICIENT INFORMATION TO DETERMINE IF THIS DEVICE BEHAVED IN THE MANNER DESCRIBED IN THE ADVISORY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO GUIDANT FOR ANALYSIS. GUIDANT WILL CONTINUE TO INVESTIGATE THE COMPLAINT, AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE REOPENED. IN JUNE, 2005, GUIDANT ISSUED A PHYSICIAN COMMUNICATION REGARDING A DETERIORATION IN WIRE INSULATION WITHIN THE LEAD CONNECTOR BLOCK THAT MAY, WITH OTHER FACTORS, RESULT IN AN ELECTRICAL SHORT CIRCUIT. GUIDANT ALSO ISSUED AN ADVISORY UPDATE ON DECEMBER 21, 2005 WITH ADDITIONAL INFORMATION RELATED TO THIS ISSUE. MANUFACTURING CHANGES TO PREVENT THIS FAILURE WERE MADE IN APRIL AND NOVEMBER OF 2002. THIS DEVICE WAS MANUFACTURED BEFORE APRIL, 2002, AND IS INCLUDED IN THIS POPULATION. WHILE THIS DEVICE WAS PART OF THE ADVISORY POPULATION, GUIDANT DOES NOT HAVE SUFFICIENT INFORMATION TO DETERMINE IF THIS DEVICE BEHAVED IN THE MANNER DESCRIBED IN THE ADVISORY.

    Description of Event or Problem · 1

    GUIDANT RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A LEGAL NOTIFICATION AND THE PATIENT PASSED AWAY. GUIDANT HAS NO SPECIFIC INFORMATION AS TO ANY DEVICE INVOLVEMENT IN THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    GUIDANT RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A LEGAL NOTIFICATION AND THE PATIENT PASSED AWAY. GUIDANT HAS NO SPECIFIC INFORMATION AS TO ANY DEVICE INVOLVEMENT IN THE PATIENT'S DEATH. NEW INFORMATION RECEIVED INDICATES THAT THE CAUSE OF DEATH WAS LISTED AS CONGESTIVE HEART FAILURE AND CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death