BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIPHERAL NERVE STIMULATOR

    MDR report key: 1059824 · Received June 12, 2008

    Report

    Report Number
    9611451-2008-00365
    Event Type
    Other
    Date Received
    June 12, 2008
    Report Date
    May 20, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BXN
    PMA / PMN Number
    K882438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL BE CARRIED OUT ONCE WE RECEIVE THE COMPLAINT DEVICE. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN ANOTHER COUNTRY, REPORTED THAT A PT GOT A MINOR BURN WHILE THE PERIPHERAL NERVE STIMULATOR WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL NERVE STIMULATOR BXN FISHER & PAYKEL HEALTHCARE, LTD. NS252AUU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention