BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1852637 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14357
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE COMPLETE LEAD WAS PERFORMED. VISUALLY, THE LEAD WAS RETURNED WITH THE HELIX RETRACTED AND DRIED BLOOD WAS OBSERVED IN THE LUMEN AND DRIED TISSUE WAS FOUND ON THE HELIX. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY; MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ELECTRICALLY, THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION AND THE ALLEGATION OF DISLODGEMENT COULD NOT BE CONFIRMED BY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING IMPLANT, THIS RIGHT VENTRICULAR (RV) PACE/SENSE LEAD EXHIBITED HIGH PACING THRESHOLDS (< 4.5V AT 0.5MS) SO MULTIPLE ATTEMPTS WERE MADE TO REPOSITION THE LEAD. DESPITE INCREASED THRESHOLDS, THE RIGHT ATRIAL LEAD WAS IMPLANTED AND THE POCKET WAS CLOSED. ANOTHER MEASUREMENT SHOWED CONTINUED, INCREASED THRESHOLDS AND DECREASED SENSING SO THE POCKET WAS REOPENED TO REPOSITION THE RV LEAD; DESPITE ADDITIONAL ATTEMPTS TO REPOSITION THE LEAD, IT CONTINUED TO DISLODGE SO THE RV LEAD WAS FINALLY EXPLANTED. UPON EXPLANT, THE PHYSICIAN NOTED DIFFICULTY WHEN THEY TRIED TO EXTEND THE HELIX USING THE FIXATION TOOL SO THE RV LEAD WAS REPLACED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1