BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ENHANCED

    MDR report key: 20862491 · Received December 6, 2024

    Report

    Report Number
    2182207-2024-04772
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    December 4, 2024
    Report Date
    February 13, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 306001 LOT# 60517674 SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE SCREENING DEVICE SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 306001, SERIAL/LOT #: (B)(6), UBD: 27-NOV-2025, UDI#: (B)(4) 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

    H6: ANALYSIS OF THE LEAD (LOT#: 60517674) REVEALED THE BODY OF THE LEAD WAS STRETCHED. CONTINUATION OF D10: PRODUCT ID 306001 LOT# 60517674 SERIAL# UNKNOWN: PRODUCT TYPE SCREENING DEVICE. PRODUCT ID NEU_STYLET_ACC. SERIAL# UNKNOWN: PRODUCT TYPE ACCESSORY. PRODUCT ID 041838. SERIAL# UNKNOWN: PRODUCT TYPE ACCESSORY. 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

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SENT ONCE ANALYSIS IS COMPLETE. 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 BEING IMPLANTED WITH A LEAD FOR AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY WERE AT A BASIC EVALUATION CASE TODAY. CALLER REPORTS THE LEAD WAS IN THE PATIENT'S FORAMEN, BACK OUT OF THE SKIN, REMOVED THE STYLET, THE STYLET WOULD NOT COME OUT AND HAD STRETCHED THE LEAD. CALLER REPORTS PHYSICIAN HAD TO PULL EVERYTHING OUT. REVIEWED LEAD WAS BEING SENT BACK FORANALYSIS. CALLER REPORTS PATIENT WAS DOING FINE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REPRESENTATIVE. THEY REPORTED ON (B)(6) 2024 THE LEAD WAS THROUGH THE NEEDLE WHICH WAS IN PATIENTS' FORAMEN. STYLET COULD NOT BE PULLED OUT OF THE LEAD; THEREFORE, NEEDLE COULD NOT BE REMOVED. EVERYTHING HAD TO BE REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516572 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female "SEE H11....".