BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2041648 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00999
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. 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

    SUBSEQUENT INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED AND HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS DEVICE DECLARED A BATTERY STATUS OF END OF LIFE (EOL). AS OF TODAY, NO INTERVENTION HAS BEEN PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 0148| T177| 1852