BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTIV

    MDR report key: 22187576 · Received June 11, 2025

    Report

    Report Number
    3004209178-2025-10033
    Event Type
    Injury
    Date Received
    June 11, 2025
    Report Date
    June 11, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000540302
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260 SERIAL# (B)(6) IMPLANTED: (B)(6) 2025 PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 22-NOV-2028, 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.

    Description of Event or Problem · 0

    (B)(6) 2025 MPXR (B)(6) (): THERE WAS PATIENT DISCOMFORT, SORENESS, PINCHING, AND IRRITATION, WHICH WERE ATTRIBUTED TO A SHALLOW LEAD TENSION LOOP. IMPEDANCE ISSUES WERE NOTED DURING THE PROCEDURE, SPECIFICALLY AT CONTACT 9 (33161) AND CONTACT 14 (B)(6). THE INCISION WAS REOPENED AND THE LEAD WAS BURIED DEEPER IN THE TISSUE TO ADDRESS THE IRRITATION. THE SURGEON WAS INITIALLY ADVISED TO USE BIPOLAR BOVIE BUT USED MONOPOLAR AT LOW SETTINGS; AFTER IMPEDANCE ISSUES WERE OBSERVED, THE SURGEON SWITCHED TO BIPOLAR BOVIE. THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96594 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

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