BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 13065562 · Received December 22, 2021

    Report

    Report Number
    3004209178-2021-18974
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    October 22, 2021
    Report Date
    December 22, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97745; SERIAL#: (B)(4); PRODUCT TYPE: PROGRAMMER, PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT PATIENT WAS RECENTLY IMPLANTED AND THEY NOTICED WHEN THEY ARE IN GROUP C THEY SOMETIMES FEEL THE STIMULATION AND SOMETIMES DO NOT FEEL THE STIMULATION; PT SAID THEY HAVE THE INTENSITY TURNED UP REALLY HIGH IN C. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT SAID THEY HAVE AN UPCOMING APPOINTMENT WITH THEIR DOCTOR AND THEY WILL ADDRESS THE ISSUE THEN. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT CLARIFYING THE REPORT OF FEELING STIMULATION SOMETIMES AND SOMETIMES NOT ON GROUP C, BY STATING THAT THERE WAS A CHANGE. THEY STATED THAT THEY NOW DON¿T HAVE THE RIGHT AND LEFT OPTION. THEY STILL WERE NOT VERY SURE ON WORKING OF UNIT. THEY HAD THE STIMULATION FEELING DOWN THEIR LEG, BUT THEIR LEGS WERE NEVER A PROBLEM, IT WAS ALWAYS THEIR BACK AND HIPS. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT STATED THAT THEIR SURGEON WAS NOT THERE THE DAY THEY WENT IN. THE PATIENT NOTED THAT THEY STILL HAD TIMES WHEN THEY DON¿T FEEL STIMULATION. THE PATIENT NOTED THAT THEY HAD BEEN GOING THROUGH SO MUCH THE LAST TWO MONTHS WITH FAMILY THAT THEY HAD NOT BEEN IN CONTACT WITH THEIR REP LIKE THEY SHOULD. THEY STATED THAT THEY HOPED THIS CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961007 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female