BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-2 PATIENT INTERFACE PROTECTED PIN

    MDR report key: 289318 · Received August 14, 2000

    Report

    Report Number
    1045254-2000-00013
    Event Type
    Injury
    Date Received
    August 14, 2000
    Date of Event
    January 1, 2000
    Report Date
    August 7, 2000
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    IKN
    Removal / Correction Number
    1045254-8/2/00-001R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR REPORTED: "NERVE WAS DAMAGED (NICKED) WHILE USING NIM SYSTEMS IN CONJUNCTION WITH THE NOW-RECALLED PT INTERFACE. PT INTERFACE PROBLEMS WERE THE CAUSE OF THE INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM-2 PATIENT INTERFACE PROTECTED PIN NERVE MONITORING ACCESSORY IKN MEDTRONIC XOMED NA 19609700

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention