BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1945067 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20613
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH THE HELIX RETRACTED AND DRIED BLOOD PAST THE HELIX MECHANISM UP THROUGH THE LEAD LUMEN. DEFORMED CONDUCTOR COILS AT 112 AND 135 MM FROM THE TERMINAL PIN AND CUTS IN THE INSULATION FROM 108 TO 112 AND 136 TO 135 MM FROM THE TERMINAL PIN WERE ALSO NOTED. IT WAS DETERMINED THAT THE DEFORMED CONDUCTOR COILS AND CUTS IN THE INSULATION WERE DUE TO THE USE OF A GRABBING TOOL. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. THE FIELD ALLEGATION WAS NOT ABLE TO BE CONFIRMED BY LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENFIC CRM RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 4479| 4087| S603| 4086