BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 21197777 · Received January 21, 2025

    Report

    Report Number
    3004209178-2025-01135
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    January 7, 2025
    Report Date
    January 21, 2025
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME VECTRIS SURESCAN; PRODUCT ID: 977A290 (SERIAL: (B)(6); PRODUCT TYPE: 0200-LEAD. 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 VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT A HIGH IMPEDANCE ISSUE OCCURRED WITH THE LEAD, AND "UNABLE TO PROVIDE DESIRED INTENSITY" WAS OBSERVED. THE HIGH IMPEDANCE WAS NOT OBSERVED ON THE DAY OF SURGERY, AND SPECIFIC IMPEDANCE VALUES WERE RECORDED FOR ELECTRODES 8 THROUGH 14; ELECTRODE 8- 30060, 9- 32960, 10- 29800, 11- 32750, 12- 30890, 13- 32130, 14- 31350. TROUBLESHOOTING STEPS INCLUDED PERFORMING AN IMPEDANCE CHECK AND RUNNING LEAD SELECT MEASUREMENTS. THE ISSUE REMAINS ONGOING, AND NO RESOLUTION HAS BEEN ACHIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742632 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female SEE H11.