BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSEP LEAD

    MDR report key: 330142 · Received May 1, 2001

    Report

    Report Number
    MW1021757
    Event Type
    Malfunction
    Date Received
    May 1, 2001
    Date of Event
    April 2, 2001
    Report Date
    April 20, 2001
    Manufacturer
    GRASS INSTRUMENT CO. DIV ASTRO-MED INC.
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SSEP LEAD BROKE OFF IN RIGHT CALF. 2CM INCISION REQUIRED TO LOCATE AND EXTRACT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19886 SSEP LEAD SUBDERMAL PLATINUM NEEDLE ELECTRODE GXZ GRASS INSTRUMENT CO. DIV ASTRO-MED INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other