BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK AV

    MDR report key: 151096 · Received February 8, 1998

    Report

    Report Number
    2124215-1998-00019
    Event Type
    Injury
    Date Received
    February 8, 1998
    Date of Event
    May 12, 1997
    Report Date
    December 15, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    Z242/243-8
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED AN ABNORMAL RISE IN ATRIAL LEAD IMPEDANCE. THE ICD WAS REPROGRAMMED FROM DDD MODE TO VDD MODE AND REMAINS IMPLANTED. APPROPRIATE SENSING AND PACING WAS OBSERVED IN THE VENTRICULAR CHANNEL. CPI LEARNED THAT THE ICD WAS EXPLANTED ON DECEMBER 08, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK AV Implant IMPLANTABLE CARDIOVERTOR DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention THE DEVICE 1821/200270 WAS IMPLANTED 08-DEC-1997