BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2908704 · Received January 10, 2013

    Report

    Report Number
    2124215-2012-14750
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    October 22, 2012
    Report Date
    November 14, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATIONS CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED WITH THE HELIX RETRACTED AND THERE WAS DRIED BLOOD AND TISSUE NOTED IN THE HELIX AND THROUGHOUT THE LEAD LUMEN. THE CONDUCTOR COILS WERE FOUND TO BE DEFORMED AT 122 MM FROM THE TERMINAL PIN, AND THERE WERE CUTS IN THE INSULATION AT 122, 192, 210 AND A GOUGE FOUND AT 371 - 375 MM FROM THE TERMINAL PIN. ANALYSIS CONCLUDED THAT THERE IS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED INCREASED THRESHOLDS AND LOSS OF CAPTURE. IT WAS NOTED THAT THE LEAD MICRO DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED, AND SHORTLY THEREAFTER, LOSS OF CAPTURE WAS ONCE AGAIN OBSERVED. AS A RESULT THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13478 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 4088| S603| 4473| V173| 4592