BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II VR

    MDR report key: 1831577 · Received September 11, 2010

    Report

    Report Number
    2017865-2010-03625
    Event Type
    Malfunction
    Date Received
    September 11, 2010
    Date of Event
    June 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 AFTER PUSHING THE BUTTON TO TEST VIBRATION ALERT, THE PATIENT DID NOT FEEL ANY VIBRATION, NOR DID THE PHYSICIAN WHILE PLACING HANDS ON THE PATIENT OVER THE IMPLANTED DEVICE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1