BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL VR

    MDR report key: 1955213 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00485
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 29, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND IN THE AUTOMATED TEST SYSTEM. NO OUT OF RANGE HV IMPEDANCES WERE DETECTED. THE HIGH HVLI AND RESULTANT ALERT IS CONSISTENT WITH AN OPEN LOAD SHOCK. IT IS BELIEVED, THE DEVICE WAS PROGRAMMED ON AND DELIVERED A HIGH VOLTAGE SHOCK DUE TO OVERSENSED NOISE. THE STORED EGM HAD VENTRICULAR NOISE OF UNKNOWN ORIGIN AND NO INTRINSIC SIGNALS WERE OBSERVED.

    Description of Event or Problem · 1

    DURING INDUCTION TESTING, AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE WAS OBSERVED. THE POCKET WAS RE-OPENED TO EXPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT ACCEL VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention