BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1860354 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14881
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    May 20, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, BOTH THE MECHANICAL AND THE ELECTRICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WERE SCRUTINIZED. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS. THE LEAD WAS RETURNED WITHOUT THE DRUG COLLAR IN PLACE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS ATTEMPTED AND NOT USED. DURING THE IMPLANT PROCEDURE, THIS LEAD SEEMED TO GET INTERTWINED IN WHAT APPEARS TO BE TRICUSPID VALVE TISSUE. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED IN IT'S PLACE WITHOUT INCIDENT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4469| 4470| S603