BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 21976122 · Received May 7, 2025

    Report

    Report Number
    3004209178-2025-07877
    Event Type
    Injury
    Date Received
    May 7, 2025
    Report Date
    June 5, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 39565-65, SERIAL/LOT #: VA022AD029, UBD: 14-AUG-2016, (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

    CONTINUATION OF D10: PRODUCT ID 39565-65, SERIAL# (B)(6), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2025, PRODUCT TYPE: 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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD 39565-65 SURGICAL LEAD WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP NOTED IMPEDANCE ISSUES WITH THE PATIENT¿S 39565-65 LEAD WHEN THEY WERE REPLACING THE INS. THE SURGEON AND PATIENT AGREED THAT IF THEY AROSE INTRAOPERATIVELY THAT THEY WOULD REPLACE THE LEAD FOR MRI COMPATIBILITY. NO DIRECT CAUSE WAS DETERMINED. THE LEAD WAS REPLACED. THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    REP REPORTED THAT THE INS REPLACEMENT WAS PROPHYLACTIC. THE SURGEON AND PATIENT BOTH THOUGHT THAT THERE WAS A BENEFIT TO BE HAD BY UPDATING THE DEVICE. THE IMPEDANCE VALUES WERE AS FOLLOWS: 0: - ,1: 870, 2: 1010, 3: 1020, 4: 40000, 5: 880, 6: 850, 7: 970, 8: 37230, 9: 1000, 10: 22940, 11: 39010, 12: 1080, 13: 39210, 14: 970, 15: 1020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479663 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention "SEE H11...."