BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 20089210 · Received August 28, 2024

    Report

    Report Number
    2182207-2024-03671
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Report Date
    August 28, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME LEAD; PRODUCT ID NEU_UNKNOWN_LEAD (SERIAL: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE D. 6A: IMPLANT DATE IS MONTH AND YEAR VALID. G2: THE COUNTRY OF THE EVENT IS DE H6 CODES REFER TO 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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD AN OOR (OUT OF REGULATION) AND ONE KNOWN DEFECTIVE POLE ON A LEAD. IT WAS NOTED THAT THE MESSAGE IS CAUSED BY THE INS AND NOT THE HANDSET. THEY WERE REFERRED TO THE HOSPITAL AND AN APPOINTMENT HAS MADE FOR THE NEXT DAY. THEY WILL CHECK IMPEDANCES AND MOST LIKELY REPLACE THE LEAD. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS VERY UNSPECIFIC REGARDING THE DATES OF OCCURRENCE. THE FIRST OOR STARTED SOME TIME AFTER THEY HAD ANOTHER ISSUE RESOLVED AND AN IMPEDANCE CHECK REVEALED ONE DEFECTIVE ELECTRODE, ACCORDING TO THE PATIENT. FOR A WHILE, EVERYTHING WAS FINE UNTIL VERY RECENTLY A NEW OOR SHOWS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179960 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

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