BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 23200749 · Received October 2, 2025

    Report

    Report Number
    3004209178-2025-16694
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Report Date
    October 29, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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.

    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

    THE REPRESENTATIVE (REP) REPORTED PATIENT FELT A "SURGE" OF STIM WHEN USING THE LZR ULTRABRIGHT DEVICE. CALLER DESCRIBED THE DEVICE AS BEING A LASER/RED LIGHT THERAPY DEVICE. CALLER INQUIRED ABOUT COMPATIBILITY. AGENT REVIEWED COMPATIBILITY FOR BOTH DEVICES (LZR ULTRABRIGHT AND NEUROSPA [NEUROPATHY STIMULATOR]). AGENT SUGGESTED ALSO REACHING OUT TO BOTH MANUFACTURERS. CALLER SAID THEY WOULD REACH OUT TO THE PATIENT AND WIFE (CAREGIVER) AND REVIEW THIS INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) STATING THE CAUSE WAS UNKNOWN. THEY INSTRUCTED PATIENT NOT TO PLACE DEVICE DIRECTLY OVER SPINAL CORD STIMULATION SYSTEM. ADDITIONALLY, SUGGESTED PATIENT TURN STIMULATION OFF WHILE OTHER DEVICE WAS IN USE. UNKNOWN IF THE ISSUE IS RESOLVED. THEY FOLLOWED UP WITH THE PATIENT BUT HAVE NOT RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317853 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male