BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 10101529 · Received May 29, 2020

    Report

    Report Number
    3004209178-2020-09373
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    December 1, 2019
    Report Date
    May 29, 2020
    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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 11-DEC-2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CONSUMER VIA MANUFACTURER'S REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION. IT WAS REPORTED THAT THE PATIENT SLIPPED ON WATER IN (B)(6) 2019 AND HAS HAD AN INCREASE IN BACK PAIN EVER SINCE. THE PATIENT DID NOT REACH OUT TO NOTIFY US OF HER FALL UNTIL TODAY 01/01/20 AT HER APPOINTMENT. REP STATED THE STIMULATOR WAS STILL HELPING HER PAIN AND THAT IF SHE TURNED IT OFF HER PAIN INCREASED. PATIENT HAD AN APPOINTMENT TODAY AND WANTED HER LEADS CHECKED UNDER X-RAY TO SEE IF THEY HAD MOVED. AN X-RAY WAS TAKEN TODAY 01/0120 TO CONFIRM LEAD PLACEMENT AND RESULTS SHOWED THAT HER LEFT LEAD MOVED DOWN 1 ELECTRODE AND THE RIGHT LEAD DID NOT MOVE. ON 01/01/20 CHECKED ELECTRODES IMPEDANCES WHICH WERE ALL WITHIN NORMAL LIMITS. REP REPROGRAMMED GROUPS B AND C TODAY TO COVER MORE LOW BACK PAIN AFTER REPROGRAMMING SHE STATED GOOD COVERAGE IN HER PAINFUL AREAS. PATIENT'S NEXT APPOINTMENT IS (B)(6) 2020. REP TO FOLLOW UP WITH HER THEN TO SEE IF ADDITIONAL PROGRAMMING IS NEEDED. ISSUE RESOLVED AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566754 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR