BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11454342 · Received March 10, 2021

    Report

    Report Number
    3010676138-2021-00035
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    February 6, 2021
    Report Date
    February 8, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    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 RECEIVED TWO NEW WAAS, AND THE SHOCKING SENSATION CEASED. (B)(4), THE INVESTIGATION FOUND NO ISSUE WITH THE UNITS AND UNABLE TO REPLICATE THE ALLEGED ISSUE. THE SETTING ON THE DEVICES FOLLOWS THE PARAMETER FOR SURGE MODE CONSISTING ON RATE 500 HZ AND WIDTH OF 800 US. AFTER THE INCIDENT, THE PATIENT WAS PROVIDED WITH REPLACEMENT DEVICES PROGRAMMED AT THE SAME PARAMETERS, AND THE ISSUE DID NOT RECUR. THE DEVICE WAS VERIFIED TO MEET SPECIFICATION, AND NO ROOT CAUSE WAS FOUND FOR THE REPORTED INCIDENT. BASED ON THIS INFORMATION, THE SHOCK/JOLT WAS NOT CONFIRMED/REPLICATED. THE MILD SHOCK FELT BY THE PATIENT COULD BE ELECTRICAL SENSATION/PARASTHESIA. BASED ON THE STIMULATOR INVESTIGATION, THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE SHOCK/JOLT IS UNKNOWN; NO PROBLEM FOUND. DESIGN FMEA 06-0537 AND HRA 06-0524 WAS REVIEWED AND PAINFUL AND OVERSTIMULATION DUE ARE KNOWN ISSUES WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT-REPORTED EXPERIENCING A SHOCKING SENSATION SO HARD THAT IT MADE THE PATIENT FALL OFF THE COUCH WHILE ACTIVATING THE WAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350675 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. PDBT-915-2K 00396-D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other