BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 21023257 · Received December 26, 2024

    Report

    Report Number
    2182207-2024-04985
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 26, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID WR9200 LOT# SERIAL# (B)(6) PRODUCT TYPE RECHARGER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: WR9200, SERIAL/LOT #: (B)(6) H3: ANALYSIS OF THE WIRELESS RECHARGER (SERIAL #:(B)(6)) REVEALED THE LED'S SCROLL CONTINUOUSLY AND THE DEVICE IS UNRESPONSIVE. FLASH SECTOR READ/WRITE PROTECTION BITS HAVE BECOME SET. 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

    ON 2024-SEP-19 MPXR 1223893 (HCP, FOR): IT WAS REPORTED THAT THE NURSE WAS PREPARING THE CHARGING SYSTEM FOR THE PATIENT AND IT WAS FLASHING LIGHTS AND NEVER COMING OUT OF SHIPPING MODE. THE CAUSE WAS UNKNOWN. THEY TRIED A RESET BUT THE ISSUE DID NOT RESOLVE. THERE WERE NO SYMPTOMS REPORTED. 2024-OCT-03 EMAIL (REP, FOR): NO NEW INFORMATION FOR EVENT DESCRIPTION. 2024-NOV-12 RPL 450806 (OTHER) NO NEW INFORMATION. 2024-11-20 E2 (FOR, REP): NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732080 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

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