BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2911186 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15824
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE REPLACEMENT PROCEDURE, BOTH THE RIGHT ATRIAL (RA) LEAD AND THE IS-1 PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WERE STUCK IN THE HEADER OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). ATTEMPTS TO RELEASE THE SETSCREWS USING BOTH TORQUE AND FIXED WRENCHES WERE UNSUCCESSFUL. THE SET SCREWS WERE DRILLED IN AN ATTEMPT TO RELEASE THEM; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. FINALLY, THE HEADER WAS CUT FROM THE DEVICE BODY AND THE RA LEAD WAS SURGICALLY ABANDONED. THE IS-1 PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED AS WELL BUT THE REST OF THE LEAD REMAINS IN SERVICE FOR DEFIBRILLATION PURPOSES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18749 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4543| H190| 4087| 0184