BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL NERVE STIMULATOR

    MDR report key: 13218792 · Received January 11, 2022

    Report

    Report Number
    3010676138-2022-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 10, 2021
    Report Date
    January 10, 2022
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020150
    PMA / PMN Number
    K171366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE REPORT OF OVERHEATING: DUE TO THE SHORT ON THE POWER AMPLIFIER (PA), THE BATTERY WOULD NEVER FULLY CHARGE AND MAY FEEL WARM WHILE CHARGING. THE WAA IS UNABLE TO PROVIDE THERAPY WHILE CHARGING; THE PATIENT WOULD NOT BE USING THE UNIT AT THIS TIME. THERMAL IMAGING WAS USED TO VERIFY THE OUTSIDE TEMPERATURE OF THE DEVICE WHILE CHARGING (FRONT AND BACK) AND THE INTERNAL TEMPERATURE WHILE CHARGING. RESULTS ARE AS FOLLOWS: FRONT OUTSIDE THERMAL TEMPERATURE WHILE CHARGING: 31.9°C, BACK OUTSIDE THERMAL TEMPERATURE WHILE CHARGING: 31.8°C, INTERNAL THERMAL TEMPERATURE WHILE CHARGING: 34.8°C. THE OUTSIDE THERMAL TEMPERATURE WHILE CHARGING WAS 31.9°C, WHICH IS BELOW THE PRODUCT REQUIREMENTS SPECIFICATION OF 41°C (106°F). BASED ON THE THERMAL IMAGING, THERE IS NO EVIDENCE OF THERMAL DAMAGE AND THE PRODUCT MET TEMPERATURE SPECIFICATIONS. ALTHOUGH THE REPORTED ISSUE OF OVERHEATING COULD NOT BE CONFIRMED, THE INVESTIGATION FOUND THE POWER AMPLIFIER WAS BLOWN - SHORTED.  THIS CAUSED HIGH CURRENT DRAW (0.6AMPS) AND PREVENTED THE BATTERY FROM FULLY CHARGING. IN ADDITION, IT CAUSED THE BATTERY TO DISCHARGE QUICKLY. REFERENCE CAPA-0042 FOR ADDITIONAL BATTERY INVESTIGATION DETAILS. IN ADDITION TO THE BLOWN POWER AMPLIFIER, THE INVESTIGATION FOUND THE UNIT BOARD WAS DAMAGED BY LIQUID INGRESS THE CAUSE IS ATTRIBUTED TO PCB FAILURE DUE TO LIQUID DAMAGE. ATTACHED TO THE INVESTIGATION REPORT IS A PICTURE THAT SHOWS THE PRESENCE OF LIQUID ON THE BOARD.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY GETS HOT AFTER TURNED ON CAUSING A BURNING SENSATION TO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537466 PERIPHERAL NERVE STIMULATOR WEARABLE ANTENNA ASSEMBLY GZF STIMWAVE TECHNOLOGIES INC. PDBT-915-2K 00455-S 00818225020150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown