BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEARABLE ANTENNA ASSEMBLY

    MDR report key: 11416260 · Received March 4, 2021

    Report

    Report Number
    3010676138-2021-00024
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 2, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    UDI-DI
    00818225020150
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CLAIMS SHE HAS NOT DROPPED, WET, OR MISUSED THEM IN ANY WAY. THE PATIENT ALSO STATED THAT OTHER THAN RANDOMLY SPARKING, THE WAS ARE FUNCTIONAL. STIMWAVE INITIATED RMAS FOR THE WAAS TO BE SENT TO HEADQUARTERS FOR FURTHER EVALUATION, BUT THE PATIENT HAS NOT BEEN RESPONSIVE TO FOLLOW-UP CORRESPONDENCE. THE PATIENT STATED THAT SHE WAS NOT HURT WHEN THE DEVICES SPARKED SINCE THE WAA WAS SITTING OUTSIDE HER CLOTHES. THIS IS IN ACCORDANCE WITH STIMQ PNS SYSTEM IMPLANTATION OF NEUROSTIMULATOR INSTRUCTIONS FOR USE ((B)(4)), WHICH STATES "THE WAA MUST BE PLACED OVERTOP A THIN LAYER OF CLOTHING OR MATERIAL AT ALL TIMES." THE PATIENT WAS HOWEVER, STARTLED BY THE SITUATION. AS OF 03/01/2021, THE BATTERIES HAVE NOT BEEN RETURNED FOR INVESTIGATION DESPITE MULTIPLE FOLLOW-UP ATTEMPTS. PER REPORTABILITY DETERMINATION AND INVESTIGATION PROCEDURE ((B)(4)), POTENTIAL CAUSES OF THE REPORTED SPARKING ISSUE INCLUDE: PCB FAILURE, BATTERY FAILURE, THERMAL CUTOFF NOT WORKING (70 °C), FIRMWARE FAILURE AND THERMAL CUTOFF NOT WORKING. UNABLE TO DETERMINE IF ANY OF THESE POTENTIAL CAUSES CONTRIBUTED TO THE REPORTED SPARKING ISSUE BECAUSE THE UNIT HAS NOT BEEN RETURNED FOR INVESTIGATION. THE PARAMETER SETTINGS WERE REVIEWED ON THE PATIENTS WAA, (4 OR 5 MA DEPENDING ON THE PROGRAM SHE IS ON, WITH 1499 HZ, 32 PW WITH AN (- - ++) ELECTRODE FORMATION). BASED ON THE COMPLAINT INFORMATION, THE PRODUCT IS WORKING WITHIN PARAMETERS. BASED ON THE AVAILABLE INFORMATION, THE REPORT OF SPARKING BATTERIES WAS NOT CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION. STIMWAVE WILL CONDUCT FURTHER INVESTIGATION IF THE PRODUCT IS RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT CONTACTED THE CLINICAL REPRESENTATIVE TO REPORT THAT TWO OF HER WAAS HAVE BEEN SPARKING RANDOMLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311126 WEARABLE ANTENNA ASSEMBLY PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. PDBT-915-2K 00383-S 00818225020150

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O