BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 1895533 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04236
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 23, 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 ANALYSIS FOUND THAT A PARITY ERROR CAUSED THE RESET MODE OBSERVED IN THE FIELD. SUBSEQUENT CLINICAL TESTING AFTER THE PRODUCT CODE DOWNLOAD RESULTED IN DAMAGE TO THE HIGH VOLTAGE OUTPUT TRANSISTORS. THE DAMAGE IS CONSISTENT WITH THAT PRODUCED BY A DAMAGED LEAD. ALTHOUGH THE LEAD WAS REPLACED, IT WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK AND FELT PALPITATIONS AND CAME TO THE HOSPITAL. INTERROGATION REVEALED BACK-UP MODE. THE DEVICE WAS SUCCESSFULLY RESTORED, BUT THE IMPEDANCE SHOWED AN INCREASE. A STATUS REPORT INDICATED A HARD FAILURE OF THE DEVICE. THE SYSTEM WAS REPLACED.

    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 72 YR Required Intervention (B)(4)