BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2040660 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00592
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    May 20, 2011
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ONGOING. ONCE ANALYSIS IS COMPLETE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY THIS DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE MONITORING VOLTAGE WAS 3.06 VOLTS AND CHARGE TIME WAS 10 SECONDS DURING PRE-IMPLANT TESTING. THE BOXED VOLTAGE IS 3.25 VOLTS. THE EXPIRATION DATE ON THE DEVICE IS IN THE NEAR FUTURE. A CAPACITOR REFORM WAS PERFORMED AND THE BATTERY STATUS DID NOT REVERT BACK TO BEGINNING OF LIFE (BOL). BOSTON SCIENTIFIC TECHNICAL SERVICES RECOMMENDED SENDING BACK THE DEVICE FOR TESTING AS THE MONITORING VOLTAGE WAS NOT WITHIN 0.1 VOLTS OF THE BOXED VOLTAGE. 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 T135

    Patients

    Seq Age Sex Outcome Treatment
    1