BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11630139 · Received April 7, 2021

    Report

    Report Number
    3010676138-2021-00061
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 1, 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 WAS IN THE ER FROM (B)(6) 2021, THROUGH (B)(6) 2021. ON (B)(6) 2021, STIMWAVE BECAME AWARE THAT THE ER STAFF CUT THE TRIAL LEAD EXTENSIONS PROTRUDING FROM THE EPIDURAL SPACE TO DIAGNOSE THE PATIENT. NEUROSURGEON PULLED THE REMAINING PORTIONS TRIAL STIMULATORS ON (B)(6) 2021, WITHOUT COMPLICATION. THE CLINICAL REPRESENTATIVE CONFIRMED THAT A LAMINECTOMY WAS NOT PERFORMED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED TO TREAT PAIN. BASED ON THE INFORMATION PROVIDED BY THE CLINICAL REPRESENTATIVE AND THE HOSPITAL PHYSICIANS, THE TRIAL LEADS COULD NOT BE LINKED TO BE THE CAUSE OF THE THORACIC ANEURYSM. THE CAUSE OF THE THORACIC ANEURISM IS UNKNOWN/NO PROBLEM FOUND. HOWEVER, THE CAUSE OF THE FRACTURED STIMULATOR IS USER ERROR BECAUSE THE LEADS WERE NOT PROPERLY REMOVED PER IFU. DESIGN FMEA 06-0537 AND HRA 06-0524 WAS REVIEWED FLEX MECHANICAL DAMAGE AND FRACTURE ARE KNOWN ISSUES WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE. THUS, CAPA IS NOT REQUIRED. STIMWAVE'S GLOBAL IMPLANTED FRACTURED STIMULATOR RATE: (B)(4) AS OF (B)(6) 2020. THE FREQUENCY IS RARE AND IMPACT IS IMPORTANT. ON (B)(6) 2021 STIMWAVE BECAME AWARE THE STIMULATOR HAD BEEN INTENTIONALLY SEVERED (FRACTURED) BY THE ER STAFF. HENCE, THE COMPLAINT DUE DATE TO FDA IS (B)(6) 2021.

    Description of Event or Problem · 1

    INVESTIGATION SUMMARY ON (B)(6) 2021, A TRIAL PATIENT REACHED OUT TO THE CLINICAL REPRESENTATIVE TO DISCLOSE THAT SHE HAD BEEN RUSHED TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR A CT SCAN WHICH SHOWED A THORACIC ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527220 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-TRL-A0, FR8A-TRL-B0 SWO201029, SWO201216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention