BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR

    MDR report key: 1073153 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02510
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 30, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    THE ANOMALY OBSERVED IN THE FIELD WAS VERIFIED IN THE LABORATORY. THE HVLI MEASUREMENT FROM RV TO CAN WAS HIGH. THE DEVICE WAS TESTED ON THE AUTOMATED ELECTRICAL TEST SYSTEM AND AN ABNORMAL BEHAVIOR WAS DETECTED. THE DEVICE WAS OPENED FOR FURTHER ANALYSIS. AN ANOMALY ON ONE OF THE INSULATED-GATE BIPOLAR TRANSISTORS (IGBT) WAS IDENTIFIED. THE HYBRID SUBASSEMBLY WAS SENT TO AN OUTSIDE LABORATORY FOR FURTHER TESTING. THE FAILURE MODE WAS LOST DURING ANALYSIS. THE COMPONENT FAILURE RESULTED IN THE OBSERVED HIGH IMPEDANCE MEASUREMENT. THE CAUSE FOR THE COMPONENT ANOMALY REMAINS UNDETERMINED DUE TO LOSS OF FAILURE MODE DURING THE HYBRID SUBASSEMBLY EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT WAS SEEN FOR INDUCTION TESTING. DURING THE TESTING, THE DEVICE DID NOT CONVERT THE PATIENT OUT OF FIBRILLATION. THE PHYSICIAN SUSPECTED AN OUTPUT ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1107-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention