BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 1861090 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15534
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE REPLACEMENT OF THIS CARDIAC RESYCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE TORQUE WRENCH GOT STUCK INSIDE THE HEADER WHEN ATTEMPTING TO LOOSEN THE RIGHT VENTRICULAR LEAD SETSCREW. THE PHYSICIAN ELECTED TO CUT THE RIGHT VENTRICULAR (RV) LEAD PACE/SENSE PORTION AND IMPLANTED A COMPETITOR LEAD. DURING THE SAME EXPLANT PROCEDURE IT WAS ALSO NOT POSSIBLE TO LOOSEN THE SETSCREWS OF THE RIGHT ATRIAL LEAD PORT. THE RIGHT ATRIAL (RA) LEAD WAS ALSO CUT AND CAPPED. AT THIS TIME NO ATRIAL LEAD IS IMPLANTED. THE DEVICE WAS RETURNED FOR ANALYSIS. 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 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 5076| H195| 4518| MISMATCH| 4096| 0165