BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8366786 · Received February 25, 2019

    Report

    Report Number
    3004209178-2019-03873
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 21, 2018
    Report Date
    March 27, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT¿S DEVICE HADN¿T WORKED FOR ABOUT A YEAR AND THEY HAD JUST BEEN TAKING PAIN MEDICATIONS. THE PATIENT STATED THAT THE PAIN LEVEL WAS HIGHER THAN THEIR PAIN MEDICATIONS SO THEY WANTED TO MEET WITH THE REP TO SEE IF THEY COULD GET THE IMPLANT TO TURN BACK ON OR KNOW WHAT THE NEXT STEPS WERE. THE PATIENT ALSO STATED THAT THE IMPLANT SITE WAS REALLY HEAVY AND UNCOMFORTABLE. THE PATIENT MENTIONED THAT THEY HAD LOST A LOT OF WEIGHT. THEY WERE REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP) TO CHECK THE BATTER AND DISCUSS THE NEXT STEPS. THE ISSUE BEGAN ALMOST A YEAR AGO IN 2018. THE PATIENT MENTIONED THAT THEIR MOTHER HAD PASSED AWAY SO THEY WERE FOCUSED ON THAT WHICH WAS WHY IT HAD BEEN SO LONG SINCE THEIR DEVICE STOPPED WORKING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. CONSUMER REPORTED THEY WERE STILL HAVING PAIN. THEY REPORTED IT NEVER LEFT AND THAT THEY HAVE NERVE DAMAGE. THE PATIENT REPORTED THE PAIN WAS EXCRUCIATING, AND DRAGGING DOWN TO THEIR LEGS. THEIR PAIN WAS OFF THE CHARTS. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158929 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR