BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM SPINAL CORD STIMULATOR

    MDR report key: 10050175 · Received May 12, 2020

    Report

    Report Number
    3010676138-2020-00046
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 11, 2020
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    UDI-DI
    00818225020693
    PMA / PMN Number
    K170141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, THE PATIENT CONTACTED THE CLINICAL REPRESENTATIVE STATING SHE EXPERIENCED A SHOCKING SENSATION DURING THE MRI. THE CLINICAL REPRESENTATIVE THEN CALLED (B)(6) REQUESTING SOME INFORMATION ABOUT THE MRI THAT WAS PERFORMED ON THE PATIENT. THE REQUEST WENT UNANSWERED. ON (B)(6) 2020, THE CLINICAL REPRESENTATIVE REACHED OUT TO (B)(6) AGAIN FOR THE INFORMATION AND WAS INFORMED THAT THEY DID NOT PERFORM AN MRI ON THE PATIENT. CLINICAL REPRESENTATIVE CALLED THE PATIENT AND WAS INFORMED THAT SHE HAD CHANGED TO (B)(6) HOSPITAL RADIOLOGY INSTEAD OF (B)(6) TO HAVE THE MRI. THE MRI CONDITIONS WERE UNABLE TO BE OBTAINED FROM (B)(6). NO FURTHER ISSUES HAVE BEEN REPORTED. THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY DUE TO THE MRI CONDITIONS NOT BEING COMPLIANT TO THE INSTRUCTIONS FOR USE (DOCUMENT # 05-0234-11; PAGE 22-24), AS ONLY THE INITIAL PLANNED MRI FACILITY REQUESTED MRI SAFETY INFORMATION FOR THE PATIENT'S DEVICE. HOWEVER, THE MRI CONDITIONS COULD NOT BE OBTAINED FROM THE MRI FACILITY FOR VERIFICATION.

    Description of Event or Problem · 1

    ON MONDAY (B)(6) 2020, THE CLINICAL REPRESENTATIVE TALKED TO THE PATIENT AND SHE REQUESTED THAT (B)(6) BE CALLED BECAUSE THEY NEEDED STIMWAVE'S MRI SAFETY INFORMATION AND MODEL OF OUR STIMULATOR. THE CLINICAL REPRESENTATIVE SPOKE WITH THE MRI FACILITY AND GAVE THEM THE WEBSITE ADDRESS TO OBTAIN THE REQUESTED INFORMATION. THE MRI FACILITY PULLED THE INFORMATION UP WHILE ON THE PHONE AND CONFIRMED THAT THE INFORMATION REQUESTED WAS THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509608 FREEDOM SPINAL CORD STIMULATOR SPINAL CORD STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-RCV-A0 SWO181211 00818225020693

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening