BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3043317 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02315
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WHICH HAS BEEN OCCURRING OVER THE PAST YEAR. NO CAPTURE AND OVERSENSING WERE ALSO NOTED. THE ISSUE WAS NOT KNOWN AS THE PATIENT HAS BEEN LOST TO FOLLOW UP. SCIENTIFIC TECHNICAL SERVICES (TS) BELIEVES THE LEAD IS FRACTURED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND THERE ARE NO PLANS TO ADDRESS THE ISSUE AT THIS TIME. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147368 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4087| 4088| 1291