BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2162367 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07270
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS BEEN RETURNED. WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED DAMAGE HAD OCCURRED TO THE LEAD BODY AND DRIED BLOOD AND BODILY FLUID HAD INFILTRATED THROUGH THE HELIX HOUSING AND UP THROUGH THE LEAD LUMEN. THE LEAD WAS THEN SUBJECT TO RESISTANCE AND PRESSURE TESTING WHICH VERIFIES THE LEAD'S ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TECHNICIANS WERE UNABLE TO REPLICATE THE CLINICAL OBSERVATIONS IN THE FIELD AND THE DAMAGE FOUND TO THE LEAD DURING VISUAL TESTING WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL GENERATOR REPLACEMENT PROCEDURE, IT WAS OBSERVED THAT THE ATRIAL LEAD HAD DISLODGED AND WAS FREE FLOATING IN THE ATRIUM. IT WAS NOTED THAT SINCE IMPLANT, ATRIAL THRESHOLD MEASUREMENTS WERE INTERMITTENT AND HIGH AND SENSING WAS POOR. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, HOWEVER EXPERIENCED GETTING A NON-BOSTON SCIENTIFIC STYLET DOWN THE LEAD. THE LEAD WAS THEN SUCCESSFULLY EXPLANTED FROM THE PATIENT AND A NEW ATRIAL LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR S606| 4470| 4088| 1296| 4087