BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1970220 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01287
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 21, 2007
    Report Date
    December 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL YEARS AGO, UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE ASSOCIATED ICD WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LEADS WERE INSERTED INTO ALL PORTS WITHOUT DIFFICULTY. THE ALLEGATION OF PREMATURE BATTERY DEPLETION COULD NOT BE SUBSTANTIATED. THIS RV LEAD WAS NEVER RETURNED FOR ANALYSIS PURPOSES. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD BEEN EXPLANTED SEVERAL YEARS PRIOR TO THE FILING OF THIS REPORT WITHOUT ALLLEGATION AT THAT TIME. THE PATIENT IS NOW INDICATING THAT THE LEAD WAS NOT WORKING AND DID CAUSE PREMATURE BATTERY DEPLETION IN THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT PROVIDED THIS INFORMATION THREE YEARS AFTER THE LEAD HAD BEEN EXPLANTED WITHOUT ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ADSR01| 4479| 1290| 4034