BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 94217 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-01046
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    January 15, 1997
    Report Date
    January 15, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. CPI LEARNED THAT THIS ICD WAS EXPLANTED ON 6/25/1997 BECAUSE OF PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 3.2 CONNECTOR LWS CARDIAC PACEMAKERS 1720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R THE DEVICE 0075/000607 WAS IMPLANTED 26-JUN-1995