BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL VR

    MDR report key: 1954743 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00459
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 22, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT WAS CONFIRMED. REVIEW OF THE STORED EGM SHOWED NOISE CONSISTENT WITH EMI OR A CONNECTION ISSUE. ONCE THE DEVICE WAS RESTORED TO AS RECEIVED SETTINGS, THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED ELECTRICAL SYSTEM. NO ANOMALIES WERE DETECTED. IT IS BELIEVED THAT THE REPORTED ANOMALY WAS CONSISTENT WITH AN INTERMITTENT LEAD/DEVICE CONNECTION ISSUE OR LEAD ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSING HAD DECREASED. A MESSAGE STATING THE IMPEDANCE WAS OUT OF RANGE AT 0 OHMS WAS NOTED. THE HVLI CHECK WAS NORMAL, BEFORE AND AFTER TESTING. THE DEVICE WAS EXPLANTED.

    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 CD1215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)