BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC.

    MDR report key: 26459 · Received August 18, 1995

    Report

    Report Number
    26459
    Event Type
    Injury
    Date Received
    August 18, 1995
    Date of Event
    August 10, 1995
    Report Date
    August 18, 1995
    Manufacturer
    CARDIAC PACEMAKERS, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERROGATING ICD FOUND HIGH IMPEDANCE WITH ALERT TO CALL CO. PT BROUGHT TO OR AND FOUND RIGHT VENTRICULAR PATCH WITH HIGH IMPEDANCE AND UNABLE TO PACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC. Implant MORPHOLOGY DEFIBRILLATING PATCH LWS CARDIAC PACEMAKERS, INC. L67

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R