BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 13739391 · Received March 11, 2022

    Report

    Report Number
    3004209178-2022-03165
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Report Date
    March 11, 2022
    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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT A WHILE AGO WHEN THEY SHOPPED AT DICK'S SPORTING GOODS THEIR STIMULATOR WOULD GO CRAZY WHEN THEY GOT NEAR THE MAGNET THAT THE STORE USED TO TAKE OFF THE SECURITY TAGS ON ITEMS IN THE STORE. PT SAID THE STORE GOT RID OF THIS SO THEY HAD NOT HAD THIS HAPPEN; PATIENT SERVICES (PSS) UNDERSTOOD THE PT HAS NOT HAD THIS HAPPEN AGAIN SINCE THE STORE REMOVED THE MAGNET. PSS REPORTING PAST EVENT THAT WAS REPORTED BY THE PT ON THE CALL. PT HAD QUESTIONS ABOUT COMPATIBILITY WITH SLEEP NUMBER BED BECAUSE THE BED HAD MAGNETS IN IT. PSS REVIEWED COMBABILITY WITH THE PT AND REDIRECTED PT TO HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884921 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 Female