BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3212690 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10062
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THIS RIGHT ATRIAL (RA) LEAD WAS PREVIOUSLY PROGRAMMED OFF DUE TO A LEAD FRACTURE WHICH WAS CAUSING NOISE AND OVERSENSING. IT IS NOT KNOWN AT THIS TIME WHEN THIS LEAD WAS TURNED OFF BUT THE PATIENT¿S CURRENT FOLLOWING CLINIC JUST NOTICED THIS. DUE TO THE PATIENT¿S CURRENT METAL AND PHYSICAL HEALTH, THE LEADS WILL REMAIN IN SERVICE FOR NOW AND THE PLAN IS TO MONITOR THE PATIENT FOR THE TIME BEING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312361 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4088| 4087| 1290