BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR RF

    MDR report key: 4220979 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17398
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING MULTIPLE SHOCKS. THE DEVICE DELIVERED INAPPROPRIATE ANTITACHYCARDIA PACING (ATP) AND HIGH VOLTAGE (HV) THERAPY. PROGRAMMING CHANGES WERE MADE. THE PATIENT WILL CONTINUE TO BE MONITORED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702543 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention