BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11097064 · Received December 30, 2020

    Report

    Report Number
    3010676138-2020-00181
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 4, 2020
    Manufacturer
    STIMWAVE TECHNOLOGIES INC
    Product Code
    GZF
    UDI-DI
    00818225020402
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STIMWAVE CLINICAL REPRESENTATIVE (CR) STATED THAT THE IMPLANTING CLINICIAN VERIFIED USING ULTRASOUND THAT THE DEVICE HAD NOT MIGRATED. FOLLOWING REVISION ON (B)(6) 2020, THE PATIENT EXPERIENCED LOSS OF THERAPY AGAIN. THE PATIENT NOTED TO THE IMPLANTING CLINICIAN AND THE CLINICAL REPRESENTATIVE THAT THERE WERE TIMES WHERE NO THERAPY WAS RECEIVED, AND AT TIMES, A SHOCK STIMULATION WAS FELT A TOTAL OF 5-6 SHOCKS FOR 6 DAYS. THE IMPLANTING CLINICIAN AND THE CR MET WITH THE PATIENT AND CONFIRMED AGAIN VIA ULTRASOUND THAT THE DEVICE HAD NOT MIGRATED. THE PATIENT'S WAS WERE VERIFIED TO BE WORKING. ON (B)(6) 2020, THE PATIENT REACHED OUT TO THE CR AND STATED RECEIVING STIMULATION AGAIN AFTER APPROXIMATELY TWO WEEKS OF NOT RECEIVING THERAPY. ALSO, THE PATIENT STATED THAT ONE TRANSMITTER CAUSES THE SHOCK SENSATION THE OTHER TRANSMITTER ONLY WORKS IF THE ANTENNA IS DIRECTLY ON THE SKIN. THE LOSS OF THERAPY/SHOCK WAS NOT CONFIRMED/REPLICATED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION. LOSS OF THERAPY DESPITE A FUNCTIONING SYSTEM IS A KNOWN POTENTIAL ISSUE OF STIMULATION THERAPY. THE ELECTRICAL SENSATION COULD HAVE BEEN CAUSED BY HIGH PROGRAMMING PARAMETERS AND/OR STIMULATOR PLACEMENT AT THE NERVE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION TO REPLACE A STIMULATOR DUE TO LOSS OF THERAPY. THE ORIGINAL DEVICE WAS IMPLANTED ON (B)(6) 2020. THE PATIENT RECEIVED THERAPY FOR THE FIRST TWO MONTHS FOLLOWING THE IMPLANT PROCEDURE; HOWEVER, THERAPY CEASED AND WAS UNABLE TO BE RESTORED UNTIL THE REVISION WITH A NEW STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561869 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC STQ4-RCV-A0 SWO200320 00818225020402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R