BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMQ PERIPHERAL NERVE STIMULATOR SYSTEM

    MDR report key: 20559348 · Received October 28, 2024

    Report

    Report Number
    MW5161777
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Report Date
    October 28, 2024
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT STATED BOTH OF THEIR DEVICES DIED THIS PAST FRIDAY. DISCLAIMER STATEMENT: 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
    1891560 STIMQ PERIPHERAL NERVE STIMULATOR SYSTEM STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF STIMWAVE TECHNOLOGIES INC. FTQ4-RCV-A0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown