BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 12309808 · Received August 11, 2021

    Report

    Report Number
    3004209178-2021-12272
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    November 1, 2019
    Report Date
    August 11, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977C265, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977C265, SERIAL/LOT #: (B)(4), UBD: 18-JUN-2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT PROBABLY AROUND (B)(6) 2019, THEIR SPINAL CORD STIMULATION SYSTEM MOVED.  THE PATIENT'S SPINE ORTHO DOCTOR WHO HELPED THEM WITH THE TROUBLE THEY WERE HAVING WITH THEIR NECK TOLD THEM IT MOVED.  THE IMAGES FROM THE INITIAL IMPLANT WERE COMPARED TO AN IMAGE TAKEN LATER, WHICH WAS HOW THE ISSUE WAS IDENTIFIED.  THE PATIENT CONFIRMED THAT BOTH OF THEIR IMPLANTS WERE WORKING AND THEIR BACK WAS FEELING GOOD, AND THEY WOULD RECOMMEND THE DEVICE THEY HAVE TO PROSPECTIVE PATIENTS.  NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON (B)(6) 2021. THEY REPORTED THAT THEY WERE NOT MADE AWARE OF THE SYSTEM MOVING WHEN THE PATIENT CONTACTED THEM THE WEEK OF (B)(6) 2020. THEY WERE ONLY ASSISTING THE PATIENT WITH OBTAINING IMAGES FROM THE INITIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203634 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR