BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 19712663 · Received July 10, 2024

    Report

    Report Number
    3004209178-2024-14493
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Report Date
    July 10, 2024
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS PART OF REMEDIATION PLAN 411. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED PATIENT HAD HIGH IMPEDANCE. IMPEDANCE ON 0 - 40000 2 - 40000 4 - 40000 5 - 40000 6 - 40000 7 - 40000 9 - 40000 11 - 40000 14 - 40000 15 - 40000 . PATIENT HAD A LOSS OF STIMULATION. PROGRAMMED STIMULATION TO HELP PATIENT USING THE ELECTRODES THAT DID NOT HAVE HIGH IMPEDANCES. REP REPORTED PATIENT IS RECEIVING THERAPY; HOWEVER THE EFFECTIVENESS IS YET TO BE DETERMINED. ADDITIONAL INFORMATION FROM THE PATIENT AND REP INDICATED THAT THE PATIENT IS UNABLE TO INCREASE STIMULATION AND SHOWS "UNABLE TO GIVE DESIRED INTENSITY." THEY STATED THAT IMPEDANCES WERE GREATER THAN 40000 OHMS ON ALL BUT 4 ELECTRODES. THE REP REPROGRAMMED AROUND THE HIGH IMPEDANCE. THE ISSUE REMAINS ONGOING AT THIS TIME. THE REP STATED THAT ADEQUATE THERAPY WAS GIVEN TO PATIENT AND DOCTOR IS AWARE AND WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363114 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female