BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 1863797 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-17728
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    June 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P960040/S031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED WHETHER THE PATIENT HAD UNDERGONE A MAGNETIC RESONANCE IMAGING (MRI) SCAN, BUT IT WAS NOT BELIEVED SO. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY. AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS LATER EXPLANTED AND WAS REPLACED WITH ANOTHER BOSTON SCIENTIFIC ICD. THE EXPLANTED DEVICE HAS NOT BEEN RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED END OF LIFE (EOL) BATTERY STATUS IN JUNE. THE MONITORING VOLTAGE WAS 2.57V AND THE CHARGE TIME WAS 32 SECONDS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male 0158| T135| T135| 0158