BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1950998 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23227
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    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

    A LEAD REVISION WAS PERFORMED WERE THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED THE LEAD SAFETY SWITCH ON THE DEVICE. OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBSERVED IN BOTH BIPOLAR AND UNIPOLAR PACING MODE. A LEAD FRACTURE WAS SUSPECTED. THE PATIENT WAS REPORTEDLY IN ATRIAL FIBRILLATION AND IS PACED 80 PERCENT IN THE RV. OVERSENSING WAS OBSERVED AND STORED AS VENTRICULAR TACHYCARDIA EPISODES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 68 YR Life Threatening 1194| 4087