BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1951024 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24187
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    August 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT ONLY THE PROXIMAL SECTION OF LEAD WAS RETURNED SEVERED AT 18.2 CM FROM THE TERMINAL PIN. A SET SCREW MARK WAS NOTED ON TERMINAL PIN AND RING. VISUAL INSPECTION REVEALED THAT THE OUTER INSULATION WAS SLIGHTLY FLATTENED AND UNDERNEATH BOTH THE ANODE AND CATHODE COILS WERE FRACTURED IN SEVERAL PIECES. THE DAMAGE WAS LOCATED AT APPROXIMATELY 17 TO 17.4 CM FROM THE TERMINAL PIN. DUE TO LOCATION AND TYPE OF DAMAGE, ANALYSIS CONCLUDED THAT IT WAS MOST LIKELY DUE TO CLAVICLE FIRST RIB CRUSH. THIS FINDING COULD HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE LEAD WAS RECEIVED BY THE RETURNS LABORATORY WITHOUT EXPLANT PAPERWORK. THE REASON FOR THE EXPLANT IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS FOR AN UNKNOWN REASON. THE DEVICE WAS REPROGRAMMED TO VVI 70. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE BOSTON SCIENTIFIC SALES REPRESENTATIVE DISCUSSED THE SITUATION WITH THE CLINIC AND FOUND THAT THERE HAS NOT BEEN A SURGICAL INTERVENTION SCHEDULED FOR THIS PATIENT AND THE DEVICE REMAINS PROGRAMMED TO VVIR 70. THERE HAS BEEN NO ADVERSE PATIENT EFFECTS.

    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 77 YR S403| 4469| 4456