BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADENCE V-110 SERIES TIERED THERAPY DEFIBRILLATOR

    MDR report key: 124253 · Received October 3, 1997

    Report

    Report Number
    2938836-1997-00113
    Event Type
    Injury
    Date Received
    October 3, 1997
    Date of Event
    September 3, 1997
    Report Date
    September 3, 1997
    Manufacturer
    VENTRITEX, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SEEN BECAUSE HIS DEVICE HAD RECENTLY DELIVERED TWO SHOCKS. UPON INTERROGATION OF THE ICD, NO COMMUNICATION COULD BE ESTABLISHED. THE DEVICE WAS EXPLANTED ON 09/05/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADENCE V-110 SERIES TIERED THERAPY DEFIBRILLATOR Implant IMPLANTABLE CARDIAC DEFIBRILLATOR LWS VENTRITEX, INC. V-110C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other CPI 0064