BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 19658976 · Received July 2, 2024

    Report

    Report Number
    3004209178-2024-14034
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 30, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMUL ATOR (INS). CALLER REPORTS ALL IMPEDANCE ARE SHOWING NORMAL READING, WHEN PATIENT ATTEMPTS TO INCREASED STIMULATION, SETTING NOT AVAILABLE IS SEEN ON THE CONTROLLER. CALLER REPORTS PATIENT ATTEMPTED TO INCREASE TO 2.6MA AND 2.7MA WHEN SETTING NOT AVAILABLE IS SEEN. CALLER REPORTS GROUP A IS WHERE THE MESSAGE APPEARS. CALLER REPORTS WITH GROUP A, ELECTRODES PATIENT USING: A1: 0, 2, 8, AND 10 A2: 13 AND 15 A3: 13 AND 15 A4: 13 AND 15. ELECTRODE IMPEDANCE: REFERENCE 0 2: 990 OHMS 8: 1780 OHMS 10: 920 OHMS 13: 950 OHMS 15: 1060 OHMS REFERENCE 2 8: 1920 OHMS 10: 890 OHMS 13: 920 OHMS 15: 1030 OHMS REFERENCE 8 10: 2820 OHMS 13: 2750 OHMS 15: 2840 OHMS REFERENCE 10 13: 950 OHMS 15: 1060 OHMS REFERENCE 13 15: 960 OHMS SUGGEST REPROGRAMMING, ELIMINATING CONTACT 8 CALLER REPORTS ISSUE RESOLVED. PATIENT IS ABLE TO INCREASE STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE WAS VARYING IMPEDANCES ON ELECTRODE 8 AND 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684171 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown