BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 12348850 · Received August 20, 2021

    Report

    Report Number
    3004209178-2021-12710
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Report Date
    August 20, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE CALLER WAS IN THE CLINIC ON (B)(6) 2021 BECAUSE OF GENERAL FOLLOW UP TO ADDRESS COVERAGE ISSUE, PAIN IN MIDDLE BACK. IT WAS NOTED THE PATIENT HAD SLIPPED IN THE TUB A COUPLE OF MONTHS AGO BUT THERE WERE NO KNOWN ISSUES WITH THE FALLING OTHERWISE. THE PATIENT FELT A PINCHING IN THE MID BACK WITH STIM OFF AND IT FELT STRONGER WHEN STIM WAS ON AND UP INTO THE SHOULDER BLADE. IT WAS NOT KNOWN WHEN THE PATIENT LAST HAD GOOD COVERAGE. IMPEDANCES SHOWED EVERY COMBINATION >10000 AND THEN >20000 AND COULD NOT TOLERATE TESTING AT 3V. X-RAYS AND POSSIBLE REVISION WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248586 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1