BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2153652 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-07481
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RE-POSITIONED RA AND RV LEADS WERE THEN INSERTED INTO THE ICD. WHEN THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE TESTED THIS RA LEAD, HE NOTICED THAT THERE WAS NOISE PRESENT AND PACE IMPEDANCE WAS GREATER THAN 2000 OHMS. THIS RA LEAD WAS THEN TAKEN BACK OUT. THE PHYSICIAN HAD NOTICED PRIOR TO REMOVING THIS RA LEAD WHEN LOOKING AT THE DEVICE HEADER, THAT THE IS-1 TERMINAL PIN APPEARED BENT. THE PHYSICIAN THEN USED A HEMOSTAT TO BEND THIS RA LEAD BACK INTO PROPER SHAPE, AND RE-INSERT THIS LEAD. LEAD MEASUREMENTS WERE THEN ALL WITHIN NORMAL LIMITS, THE SAME AS PRE-PROCEDURE. NO DEFIBRILLATION THRESHOLDS (DFT) TESTING WAS DONE. IT WAS CONFIRMED THAT THERE WAS NO PACEMAKER INHIBITION, THE PATIENT WAS NOT DEPENDENT, AND THERE WAS NO INAPPROPRIATE THERAPY. THE BOSON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE OBTAINED THE SCREWDRIVER AND PIECES OF BOTH EXTENDERS AND WILL BE SENDING THEM BACK TO BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT ATRIAL LEAD AND ASSOCIATED EXTENDER WERE PART OF A REVISION PROCEDURE. THIS PROCEDURE WAS TO REVISE THE LOCATION OF THE PATIENT'S DEVICE SYSTEM FROM ABDOMINAL IMPLANT FOLLOWING THE COMPLETION OF RADIATION THERAPY. THE REVISION PROCEDURE WAS PROLONGED WHEN A STUCK SETSCREW OF THE ICD COULD NOT INITIALLY BE LOOSENED, AND THE PHYSICIAN SUBSEQUENTLY EXPERIENCED A CUT FROM A WRENCH THAT BENT WHILE ATTEMPTING TO LOOSEN THE SETSCREW. THE EXTENDER ON THIS RA LEAD WAS EVENTUALLY PARTIALLY TAKEN APART AND REMOVED. THE OTHER EXTENDER IN THE SYSTEM ASSOCIATED WITH THE RIGHT VENTRICULAR LEAD WAS REMOVED WITHOUT ISSUE. BEYOND THE PROLONGED TIME IN SURGERY FOR THE PATIENT, THERE WERE NO OTHER REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 4087| 4518| 6952| E110| 0184| 6987| T167