BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS PRO

    MDR report key: 25123424 · Received May 8, 2026

    Report

    Report Number
    3004209178-2026-07939
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000984656
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. 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 REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THEY ARE NOT ABLE TO FEEL THE STIMULATION AT THE BACK OF THEIR LEG, WHERE IT'S SUPPOSED TO BE. AGENT ASKED WHEN DID THEY NOTICE THAT THEY CAN'T FEEL THE STIMULATION AT THE BACK OF THEIR LEG AND PATIENT MENTIONED THAT IT HAS "GRADUALLY GOTTEN WORSE". AGENT HAD THE PATIENT CHANGE GROUPS; HOWEVER, OTHER GROUPS ARE NOT TARGETING THE BACK OF THE LEG - GRP A-AROUND THE RIB CAGE, GRP B-FRONT OF LEG, GRP C-SIDE OF THE LEG, D-CAN'T FEEL ANYTHING, GRP E-FRONT OF LEG. AGENT REDIRECTED THE PATIENT TO THEIR HEALTHCARE PROVIDER (HCP), PATIENT MENTIONED THAT THEY ALREADY HAVE AN APPOINTMENT THIS FRIDAY. AGENT SENT A MESSAGE TO THE FIELD FOR VISIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392578 INTELLIS PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977118 00763000984656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male