BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTON MICRO VR

    MDR report key: 1223748 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03512
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE (EVENT) OBSERVED DURING ANALYSIS, THE DEVICE COULD NOT COMMUNICATE UPON INTERROGATION. A HIGH CURRENT CONDITION WAS FOUND DURING TESTING IN THE LABORATORY. THE HIGH CURRENT WAS TRACED TO A SHORT ACROSS A CERAMIC CAPACITOR. IT IS BELIEVED THAT THE HIGH CURRENT CAUSED A PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTON MICRO VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-194 NA

    Patients

    Seq Age Sex Outcome Treatment
    1