BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1870054 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18545
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 22, 2010
    Report Date
    September 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS NOT EXPLANTED PRIOR TO THE PATIENT'S BURIAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED A MAGNET WAS LIKELY USED TO DISABLE TACHY THERAPY AND THAT IT IS POSSIBLE THAT THE TONES WERE THE RESULT OF A STUCK REED SWITCH. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINED IMPLANTED AND IT IS UNKNOWN IF THE DEVICE WILL BE EXPLANTED PRIOR TO THE PATIENT'S BURIAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN HOSPICE AND THE DEVICE HAD BEEN INTENTIONALLY PROGRAMMED OFF TO ALLOW THE PATIENT TO PASS AWAY. THE PATIENT EXPIRED A FEW DAYS LATER. AFTER THE THE PATIENT PASSED, CONTINUOUS BEEPING TONES WERE EMITTED FROM THE DEVICE. THE DEVICE WAS INTERROGATED AND A MESSAGE WAS OBSERVED INDICATING THAT A MAGNET WAS IN PLACE OVER DEVICE. THE ENABLE MAGNET USE FEATURE WAS PROGRAMMED OFF AND NO FURTHER TONES WERE EMITTED. THIS DEVICE IS INCLUDED IN THE MAGNETIC REED SWITCH, ADVISORY COMMUNICATED ON JULY 22, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR