BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1950647 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24409
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    March 1, 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

    TO DATE, INFORMATION SUGGESTS THAT BEYOND ELECTRICAL RE-PROGRAMMING TO LEAST, BOTH MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT MYOPOTENTIAL OVERSENSING WITH SUBSEQUENT PACEMAKER INHIBITION OF GREATER THAN 2 SECONDS AT ONE TIME. THE NOISE OVERSENSING ISSUE COULD NOT BE REPRODUCED WITH ISOMETRICS. HOWEVER, THE MEDICAL CARE PERSONNEL DID RE-PROGRAM THE DEVICE TO LEAST SETTING IN ORDER TO MITIGATE SINCE THE PATIENT IS PACEMAKER DEPENDANT. IT WAS NOTED BY THE LOCAL AREA SALES REPRESENTATIVE THAT THE MYOPOTENTIAL OVERSENSING DID OCCUR AT AN AIRPORT AND THAN ELECTROMAGNETIC INTERFERENCE (EMI) MAY HAVE BEEN A CAUSE.

    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 77 YR (B)(4)| (B)(4)| (B)(4)