BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 25051830 · Received April 30, 2026

    Report

    Report Number
    3004209178-2026-07525
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    January 1, 2025
    Report Date
    April 30, 2026
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ; PRODUCT ID 377775 (LOT: V007918); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2006; EXPLANT DATE BRAND NAME ; PRODUCT ID 377775 (LOT: V011056); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2006. 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) REGARDING AN IMPLANTED NEUROSTIMULATOR (INS). PATIENT AND HER BOYFRIEND STATED PATIENT WENT TO GET AN MRI AND THE CONTROLLER SHOWS HEAD ONLY MRI. PATIENT REPORTED ABOUT A YEAR AGO SHE WAS TOLD ONLY ONE WIRE IS WORKING AND THE REST ARE NOT WORKING. PATIENT STATED THE IMPLANT WAS DONE IN PUERTO RICO AND THEY DON'T HAVE A DOCTOR (HCP) IN THE USA. PATIENT ASKED TO GET THE INS REPROGRAMMED BECAUSE ITS NOT FEELING THE SAME. AGENT REVIEWED MRI INFORMATION. AGENT REVIEWED REPS ROLE AND RECOMMEND PATIENT CONSULT WITH DOCTOR'S OFFICE FOR NEXT STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373434 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female SEE H11...