BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1970227 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01288
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 30, 2010
    Report Date
    February 7, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE COULD NOT BE TELEMETERED. THIS INFORMATION COMPLETES THE INVESTIGATION ASSOCIATED WITH THIS REPORT. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNSUCCESSFULLY ATTEMPTED FOR INTERROGATION. THE REASON FOR INABILITY TO INTERROGATE COULD NOT BE IDENTIFIED. THE PATIENT HAD BEEN LOST TO FOLLOW UP FOR APPROXIMATELY THREE YEARS. THE PATIENT REFERENCED HAVING PASSED OUT SEVERAL TIMES SINCE RETURN TO FOLLOW UP. THIS ICD WAS SUBSEQUENTLY REMOVED FROM SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS BEYOND THE NEED FOR EARLY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 4470| T125| 0185