BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORESENSOR SURESCAN MRI

    MDR report key: 15844220 · Received November 21, 2022

    Report

    Report Number
    MW5113426
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    April 9, 2014
    Report Date
    November 21, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IMPLANT WAS MISREPRESENTED TO ME AND IS JUST SETTING IN MY BODY CAUSING PAIN IT WAS IMPLANTED (B)(6) 2014 APPROXIMATELY 9 YEARS AGO.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 11/22/2022 FOR MW5113426. MY NAME IS (B)(6) HAD STIMULATOR IMPLANTED IN (B)(6) 2014 THIS THING HAS CAUSED NOTHING BUT TROUBLE MY BACK HURTS DAILY FEELS LIKE I GET SHOCKED SOMETIMES AND BURNS A LOT AND I THINK THE LEADS HAVE SHIFTED BECAUSE MY BACK WILL LOCK UP SOMETIMES MAKING ALMOST IMPOSSIBLE TO WORK OR ANYTHING ELSE. I FEEL LIKE THE PRODUCT WAS MISREPRESENTED BY THE SELLER OF THIS DEVICE AND FROM DAY ONE WAS A BIT LEARY OF THE IMPLANT BUT WAS TOLD HOW WONDERFUL AND GREAT THIS PRODUCT WAS AND HOW IT WOULD ELEVATE MY BACK PAIN THEY REASSURED ME OF THIS BUT NOW HERE I SIT WITH A USELESS IMPLANT THAT IS CAUSING PAIN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 04/03/2023 FOR MW5113426 TO ADD PROCODE OJX.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 04/20/2023 FOR MW5113426 TO ADD PROCODE LGW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707898 RESTORESENSOR SURESCAN MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC, INC. 97714
    2946528 RESTORESENSOR SURESCAN MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC, INC. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male ZEGRID