BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 1073492 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02271
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 28, 2008
    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 Location
    FL
    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

    ANALYSIS CONFIRMED THE REPORTED RESET VIA REVIEW OF THE DEVICE IMAGE. HOWEVER, THE RESET COULD NOT BE REPRODUCED IN THE LABORATORY. TESTING ON THE BENCH AND ON THE AUTOMATED TEST EQUIPMENT DETECTED NO ANOMALIES AND THE DEVICE MET ALL SPECIFICATIONS. THE CAUSE OF THE RESET WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS CLOSING THE POCKET AT IMPLANT, A VIBRATORY NOTIFIER ALERTED. THE POCKET WAS CLOSED AND THE PHYSICIAN ATTEMPTED TO RESTORE THE DEVICE VIA THE ENGINEERING TEST PAGE. INTERROGATION INDICATED THAT THE DEVICE WAS IN HARDWARE RESET. THE DEVICE WAS THEN REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECEASED. IT WAS NOTED THAT THE LEAD EXHIBITED A MECHANICAL PROBLEM. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention