BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1952823 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23806
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. PACING, SENSING, AND SHOCKING FUNCTIONS WERE VERIFIED PER BENCH TOP TESTING. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (DEVICE BATTERY HAS REACHED END OF LIFE (EOL)). THE LOCAL REPRESENTATIVE WAS NOTIFIED. THE INFORMATION FROM THE RED ALERT WAS REVIEWED BY THE CLINIC NURSE. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES AND WAS INFORMED THAT LATITUDE ALERT MONITORING AND REMOTE INTERROGATIONS COULD NOT BE GUARANTEED. TECHNICAL SERVICES COMMENTED THAT EOL WAS DECLARED IN (B)(6) 2010. THE MONITORING VOLTAGE AT THAT TIME WAS 2.65 VOLTS AND WAS ASSOCIATED WITH A CHARGE TIME OF 30 SECONDS. TECHNICAL SERVICES DISCUSSED THERAPY AVAILABILITY AT EOL BY CHARGE TIME AND A CHARGE TIMEOUT FAULT CODE AT 45 SECONDS. TECHNICAL SERVICES WAS INFORMED THAT THE PATIENT WAS CURRENTLY IN THE HOSPITAL DUE TO CLOSTRIDIUM DIFFICILE INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS EXPLANTED. TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC'S (B)(4) LABORATORY FOR ANALYSIS.

    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 75 YR 1861| MISMATCH| 5076| 0154| 1853| 0085| T180