BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2052828 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03566
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION. THE PATIENT HAD A RATE OF 40 BPM. IT WAS NOTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT, UNRELATED TO THE DEVICE OR LEADS, AND WAS ON A VENTILATOR. IT WAS ALSO NOTED THAT THE PROGRAMMER WAS NO ISOLATED IN THE OUTLET. IT WAS SUSPECTED THAT THE NOISE WAS A RESULT OF ELECTROMAGNETIC INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR S602| 4473| 4088| 1270