BEUDAMED
    FDA Adverse Event Other Summary report: N

    NS252 INNERVATOR

    MDR report key: 43687 · Received October 15, 1996

    Report

    Report Number
    9611451-1996-00001
    Event Type
    Other
    Date Received
    October 15, 1996
    Date of Event
    September 11, 1996
    Report Date
    October 9, 1996
    Manufacturer
    FISHER & PAYKEL ELECTRONICS LTD
    Product Code
    BXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE IN USE ON ULNAR NERVE SET AT 80MA ALL THE TIME DURING PROCEDURES. OBSERVED THAT PT WAS BURNED AT THE SITE OF THE ELECTRODES, ONE SITE LEAVING TWO BLACK DOTS, THE OTHER SITE A SMALL BLISTER. UNIT TAKEN OUT OF SERVICE AND FOUND TO BE OPERATING CORRECTLY BY BIOMEDICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NS252 INNERVATOR PERIPHERAL NERVE STIMULATOR BXN FISHER & PAYKEL ELECTRONICS LTD NS252 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other