BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2151580 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06010
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS REMAIN IMPLANTED. 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 THIS PACEMAKER AND RIGHT VENTRICULAR LEAD DISPLAYED NOISE WHICH RESULTED IN OVERSENSING AND MANY STORED VENTRICULAR TACHYCARDIA EPISODES. THE LEAD WAS PROGRAMMED TO UNIPOLAR SENSING MEASURING AT 3.2MV. TECHNICAL SERVICES WAS CONTACTED AND DISCUSSED PROGRAMMING AND FOLLOW-UP OPTIONS. THE PATIENT COMPLAINED OF DIZZINESS.

    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 75 YR 4087| 1194