BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 21594349 · Received March 13, 2025

    Report

    Report Number
    3004209178-2025-04510
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 13, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2. FOREIGN: CA E: INITIAL REPORTER PHONE NUMBER NOT REPORTED; PHONE NUMBER FOR MEDTRONIC NEUROMODULATION PROVIDED INSTEAD. 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

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO CHARGE THE IMPLANTED DEVICE; THE EXTERNAL EQUIPMENT IS FULLY CHARGED, CONNECTS WITH IMPLANT AND THAN SAYS TO 'CONTACT HCP'. NOTHING WAS REPORTED TO HAVE POSSIBLY LED TO THE ISSUE. THE PATIENT'S SON DID ALL THE TROUBLESHOOTING ON MARCH 3RD INCLUDING REMOVING THE BATTERY FROM THE PROGRAMMER AND RE-SETTING IT. THE PATIENT WAS ADVISED TO CONTACT THEIR HCP. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE CAUSE OF THE INABILITY TO CHARGE THE IMPLANT WAS NOT DETERMINED BY THE HCP; THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH THEM. THEY NOTED EXTERNAL EQUIPMENT WAS ATTEMPTED TO CHARGE THE IMPLANT AND WAS UNSUCCESSFUL. THE PATIENT WAS ADVISED TO CONTACT THEIR HCP AS THERE WERE NO EXTERNAL DEVICES IN STOCK TO REPLACE IN CASE IT IS AN EXTERNAL DEVICE ISSUE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690195 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown