BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATION SYSTEM

    MDR report key: 17526378 · Received August 12, 2023

    Report

    Report Number
    MW5133317
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    July 18, 2012
    Manufacturer
    NEUROMED INC.
    Product Code
    GZB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT PATIENT'S NEUROMED DEVICE IS STICKING OUT OF WOUND AND OUT OF PATIENT'S CHEST. PATIENT INDICATED TO THE NURSE THAT THE NEUROMED NEUROSTIMULATION SYSTEM ISN'T WORKING. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234368 NEUROSTIMULATION SYSTEM STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB NEUROMED INC. P1600B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown