BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 69206 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00367
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    July 28, 1996
    Report Date
    September 18, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MODEL 1625, SERIAL NUMBER 102338, WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE ICD HAD BEEN IMPLNATED FOR 33 MONTHS. RELIABILITY ASSURANCE TESTING IDENTIFIED PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other THE DEVICE 1640/700090 WAS IMPLANTED 28-JUL-1996| THE DEVICE 1645/800011 WAS IMPLANTED 27-JUL-1996| THE DEVICE 0056/008437 WAS IMPLANTED 27-JUL-1996