BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 18948707 · Received March 21, 2024

    Report

    Report Number
    2182207-2024-02000
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Report Date
    March 21, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 37761, SERIAL# (B)(6), PRODUCT TYPE RECHARGER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #: (B)(6), G2: THE COUNTRY OF ORIGIN IS SOUTH KOREA. H3: ANALYSIS OF THE DESKTOP CHARGER, MODEL# 37761, SERIAL# (B)(6), REVEALED THAT THE CONNECTOR PINS WERE BROKEN. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS PART OF REMEDIATION PLAN 411. 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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE CONNECTION PART WAS BROKEN AND THE ELECTRIC CABLE WIRES WERE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877057 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...."