BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMQ PERIPHERAL NERVE STIMULATOR SYSTEM

    MDR report key: 21196307 · Received January 21, 2025

    Report

    Report Number
    MW5164887
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Report Date
    January 13, 2025
    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

    CALLER STATED THAT THE PATIENT HAD AN IMPLANTED STIMULATOR FOR BLADDER CONTROL AND THE REMOTE FOR THE IMPLANT STOPPED WORKING. THE CALLER INDICATED THAT THE INFORMATION THAT THEY HAD FOR THE DEVICE WAS A SERIAL NUMBER: (B)(6) AND THE MANUFACTURE WAS STIMWAVE, THE DEVICE WAS CALLED A STIMGUARD STIM SYSTEM. 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
    555665 STIMQ PERIPHERAL NERVE STIMULATOR SYSTEM STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF STIMWAVE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown