BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 21924596 · Received April 29, 2025

    Report

    Report Number
    2182207-2025-01143
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 20, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID 977D260, SERIAL# (B)(6), PRODUCT TYPE SCREENING DEVICE. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977D260, SERIAL/LOT #: (B)(6), UBD: 19-MAR-2028, UDI#: (B)(4). G2: THE COUNTRY OF ORIGIN IS CHINA. 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

    H2. CORRECTION: PLEASE NOTE, H6 CODES B18, C20, D14, AND G02025 NO LONGER APPLY TO THIS REPORT. H3. THE RETURNED LEAD (SERIAL # (B)(6)) WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION AND ELECTRICAL TESTING. ANALYSIS IDENTIFIED THAT THE #2 CONDUCTOR WAS BROKEN 2.6 CM FROM THE DISTAL END OF THE 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 DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE TRIAL LEAD FAILED DURING SURGERY, BUT THE CAUSE OF THE FAILURE WAS NOT DISCLOSED. IT WAS NOTED THAT THE ISSUE WAS RESOLVED. SURGICAL INTERVENTION DID NOT OCCUR AND WAS NOT PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227226 EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".