BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIENT

    MDR report key: 2060037 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05678
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    July 10, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY UPGRADED AND WAS RETURNED FOR ROUTINE TESTING. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED 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 SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, DEFIBRILLATION, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON A ROUTINE DEVICE CHECK, THIS DEVICE WAS UNABLE TO BE INTERROGATED. THE MEDICAL PERSONNEL THOUGHT THAT THE PROGRAMMER RECORDER MONITOR (PRM) MAY NOT HAVE BEEN UPDATED RECENTLY. THE MEDICAL PERSONNEL WAS TO CONTACT THE LOCAL AREA SALES REPRESENTATIVE AND RESCHEDULE THE DEVICE CHECK. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 0185| 4135| E030