BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMED DUAL OCTRODE RECEIVER

    MDR report key: 303531 · Received November 8, 2000

    Report

    Report Number
    303531
    Event Type
    Malfunction
    Date Received
    November 8, 2000
    Date of Event
    April 20, 2000
    Report Date
    October 31, 2000
    Manufacturer
    ANS, ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MOTOR VEHICLE ACCIDENT AND SINCE THEN STIMULATOR HASN'T BEEN WORKING. ANALYSIS BY NEUROMED INDICATED STIMULATOR WAS WORKING FINE. CONTAINED PAIN SO ADMITTED FOR REMOVAL AND REPLACEMENT OF GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMED DUAL OCTRODE RECEIVER DORSAL COLUMN STIMULATOR GZB ANS, ADVANCED NEUROMODULATION SYSTEMS MNR916 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR