BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1874814 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17806
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    May 13, 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

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION REVEALED DRIED BLOOD PAST THE HELIX MECHANISM UP THROUGH THE LUMEN. THE CONDUCTOR COILS WERE DEFORMED AT 206 MM, THIS DAMAGE WAS LIKELY DUE TO THE SUTURE SLEEVE TIE DOWN. THERE WERE CUTS IN THE INSULATION THAT WERE LIKELY DUE TO THE REMOVAL OF THE SUTURE SLEEVE TIE DOWN. ADDITIONALLY, THERE WAS DRIED BODY TISSUE IN THE HELIX HOUSING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A RATE OF 30, DIZZINESS AND DIFFICULTY BREATHING. A THRESHOLD TEST DID NOT REVEAL LOSS OF CAPTURE WHEN USING EVOKED RESPONSE, BUT DID REVEAL LOSS OF CAPTURE ON THE SURFACE ELECTROGRAM. IT WAS CONCLUDED THAT THE LEAD WAS NOT CAPTURING AND HAD ELEVATED THRESHOLD MEASUREMENTS. AS A RESULT, THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS REPOSITIONED DUE TO INTERMITTENT LOSS OF CAPTURE AND INCREASING THRESHOLD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention