BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2041099 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00820
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 14, 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

    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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, (B)(4) FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED END OF LIFE (EOL) DUE TO A CHARGE TIME MEASUREMENT OF 30.0 SECONDS. THE MONITORING VOLTAGE WAS 2.65 VOLTS. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 54 YR Required Intervention 0185| T180