BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRITEX INC. "CADENCE"

    MDR report key: 107293 · Received July 2, 1997

    Report

    Report Number
    107293
    Event Type
    Injury
    Date Received
    July 2, 1997
    Date of Event
    March 10, 1997
    Report Date
    March 12, 1997
    Manufacturer
    VENTRITEX INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTRITEX V-110C REMOVED AND RETURNED TO VENTRITEX DUE TO PROLONGED CAPACITOR CHARGE TIMES (>25 SEC) CONSISTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRITEX INC. "CADENCE" Implant DEFIBRILLATOR IMPLANTABLE LWS VENTRITEX INC. V-110C *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization