BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1862133 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-18816
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    May 18, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD HAD BEEN SEVERED INTO TWO SEGMENTS. VISUAL INSPECTION OF THE LEAD SEGMENTS NOTED DRIED BLOOD THROUGHOUT THE ENTIRE LEAD, DAMAGED INSULATION AND DEFORMED CONDUCTOR COILS LIKELY CAUSED BY THE USE OF A GRABBING TOOL DURING THE PROCEDURE. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE LEAD. ANALYSIS WAS UNABLE TO REFUTE THE ALLEGATION OF DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS ATRIAL LEAD EXPERIENCED PHRENIC NERVE STIMULATION. THE ATRIAL LEAD ALSO DISLODGED TWICE, REQUIRING TWO REVISION PROCEDURES. IN THE FIRST REVISION THE LEAD WAS REPOSITIONED. IN THE SECOND REVISION, THE PHYSICIAN ELECTED TO EXPLANT THE LEAD. THERE WAS SOME DIFFICULTLY REMOVING THE LEAD, BUT EVENTUALLY WAS EXPLANTED AND SUCCESSFULLY REPLACED BY A NEW LEAD. 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 66 YR Required Intervention 4087| 4086| 4479| S603