BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 9976752 · Received April 20, 2020

    Report

    Report Number
    3004209178-2020-07366
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 5, 2020
    Report Date
    May 1, 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

    PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2019. PRODUCT TYPE LEAD, PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2019. PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. 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: 08-FEB-2023, UDI#: (B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 11-JAN-2023, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE LEAD MOVEMENT WAS NOT CONFIRMED YET AS PATIENT HAS NOT YET MET WITH THE MD DUE TO COVID-19. REP REPORTED THAT THE PATIENT WAS DOING BETTER UNTIL LATER THAT EVENING WHEN THEY STATED THAT PAIN RETURNED. THE PLAN WAS TO GET PATIENT IN FOR X-RAYS TO SEE WHERE HER LEAD POSITIONS WERE CURRENTLY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT ROUGHLY 6 WEEKS PRIOR TO THE REPORT, THE PATIENT WAS CARRYING A LAUNDRY BASKET AND THEY TRIPPED AND FELL OVER ONE OF THEIR DOGS. SHE FELL ON HER LEFT BUTTOCKS/HIP AND THE INS WAS LOCATED IN THE UPPER RIGHT BUTTOCKS. SHORTLY AFTER FALLING, THE PATIENT NOTICED THE DEVICE WAS CAUSING HER TO HAVE PAIN IN HER LEGS AND IT WAS NOT HELPING LIKE IT WAS PRIOR TO THE FALL. THE PATIENT WAS SUSPICIOUS THAT THE LEADS MAY HAVE MOVED. IMPEDANCES WERE CHECKED AND ALL WERE WITHIN NORMAL LIMITS. GROUP B WAS CREATED USING HD SETTINGS AT 1000/200 AND STIM WAS TURNED UP JUST BELOW WHERE THE PATIENT COULD FEEL IT. FOR THE 15 MINUTES BEFORE THE END OF THE MEETING, THE PATIENT WAS NOT HAVING THE PAIN AND THEY WERE GOING TO CALL THE REP IN ABOUT A WEEK TO LET THEM KNOW HOW SHE WAS DOING. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439804 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR