BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 1073182 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02539
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 23, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ANOMALY WAS CAUSED BY THE DETECTION OF POSSIBLE OUTPUT CIRCUIT DAMAGE. THE DEVICE WAS TESTED ON THE AUTOMATED ELECTRICAL TEST SYSTEM. THE HIGH VOLTAGE OUTPUT WAS FOUND TO BE NORMAL AND THE DEVICE MET ALL SPECIFIFICATIONS. THE DEVICE IMAGE SHOWED THE DETECTION OCCURRED AT THE DELIVERY OF A MAXIMUM VOLTAGE SHOCK, WHICH WAS AFTER THE PATIENT HAD RECEIVED THREE INDUCTIONS AND THREE HV SHOCKS WITHIN EIGHT MINUTES. THE FALSE DETECTION WAS LIKELY CAUSED BY THE TOO RAPID DETECTION OF THE FAULT CONDITION.

    Description of Event or Problem · 1

    DURING A NONINVASIVE PROGRAMMED STIMULATION (NIPS) STUDY, THE DEVICE REPORTED THAT NIPS WAS UNAVAILABLE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention