BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIM Q

    MDR report key: 17488575 · Received August 9, 2023

    Report

    Report Number
    MW5121274
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Report Date
    May 4, 2023
    Manufacturer
    UNKNOWN
    Product Code
    GZF
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR STIMWAVE WAS NOT WORKING. THE STIMWAVE STIM Q IS NOT FUNCTIONS. THEY DID AN X-RAY, CAT, AND MRI AND IT INDICATED THAT THE STIM Q ANTENNA LEADS ARE DETACHED FROM BOTH IMPLANTS. THEY INDICATED THAT NO FURTHER ACTION WILL BE TAKEN. (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
    2099726 STIM Q STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown