BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11073286 · Received December 24, 2020

    Report

    Report Number
    3010676138-2020-00184
    Event Type
    Injury
    Date Received
    December 24, 2020
    Date of Event
    November 24, 2020
    Report Date
    November 28, 2020
    Manufacturer
    STIMWAVE TECHNOLOGIES INC
    Product Code
    GZB
    UDI-DI
    00818225020679
    PMA / PMN Number
    K1710141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END OF THE CORD WHERE IT GOES INTO THE WAA CHARGER WAS MELTED. THE PATIENT IMPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2020, AND THE PATIENT WAS ON DAY SIX (6) OF THE TRIAL WHEN THIS EVENT TOOK PLACE. DURING THE COMPLAINT INVESTIGATION FOR THE WEARABLE ANTENNA ASSEMBLY, WAA. THE USB CONNECTOR APPEARED TO BE MELTED DUE TO A SHORT CIRCUIT. WE DISSEMBLED THE WAA AND CONNECTED THE MFS BOARD EXTERNALLY TO OUR TEST EQUIPMENT. THE MFS BOARD WAS FULLY FUNCTIONAL, AND IT DRAWS THE CORRECT AMOUNT OF CURRENT PROVING THAT THE BOARD DID NOT CAUSE THE SHORT CIRCUIT. AFTER FURTHER EVALUATING THE USB CONNECTOR UNDER A MICROSCOPE IT APPEARS THAT THE USB CONNECTOR PINS ARE MELTED INCLUDING THE GUIDE SHIELD. THIS SUGGESTS THE USER MAY HAVE FORCED THE USB CONNECTOR INCORRECTLY AND THE VB PIN, WHICH SUPPLIES CURRENT TO THE BOARD, MAKE CONTACT WITH THE GUIDE SHIELD OR ANOTHER SIGNAL PIN CAUSING A SHORT CIRCUIT. USB CONNECTORS ARE MISTAKE PROOF WITH ONLY ONE CORRECT WAY TO CONNECT. THERE MAY HAVE BEEN EXCESS FORCE WHEN CONNECTING THE USB FOR THIS FAILURE MODE TO OCCUR. INVESTIGATION ALSO FOUND THE DEVICE'S BATTERY IS EXPANDED (BATTERY L/N: 200408). THE CAUSE OF EXPANDED BATTERY IS ATTRIBUTED TO MATERIAL. A THERMAL IMAGE OF THE INTERNAL BOARD OF THE WAA. IN ADDITION, A THERMAL IMAGE OF THE ASSEMBLED WAA USING THE SAME CHARGER BUT DIFFERENT USB CABLE SINCE THE ONE THAT CAME ON THE RMA WAS (PICTURE ATTACHED), THE IMAGE NEAR THE CHARGING AREA IS BLUE, MEANING IT IS COOL, NO HIGHEST TEMPERATURE IS 77.4 DEGREES F AFTER 1 HOUR CHARGING. BASED ON THESE IMAGES, THERE IS NO EVIDENCE OF OVERHEATING DUE TO THE WAA. BASED ON THIS INFORMATION THE WAA OVERHEATING WAS NOT REPLICATED/CONFIRMED. THE CAUSE OF THE WAA MELTED CORD IS USER ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT CONTACTED THE CLINICAL REPRESENTATIVE TO REPORTED AN ELECTRICAL BURN SMELL COMING FROM THE WAA CHARGER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535548 FREEDOM NEUROSTIMULATOR SPINAL CORD STIMULATOR GZB STIMWAVE TECHNOLOGIES INC FR8A-TRL-A0 SWO200922 00818225020679

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other