BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 22911888 · Received August 28, 2025

    Report

    Report Number
    3004209178-2025-14562
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 21, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000984687
    PMA / PMN Number
    P840001
    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: 977A260, SERIAL/LOT#: (B)(6), UBD: 16-JUL-2029, UDI#: (B)(4); PRODUCT ID: 97 7A260, SERIAL/LOT#: (B)(6), UBD: 29-JUL-2029, 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

    IT WAS REPORTED THAT A LOW IMPEDANCE AND ELECTRICAL SHORT ISSUE WAS IDENTIFIED WITH THE LEAD 5MM COMPACT 1X8 MAGNETIC RESONANCE IMAGING (MRI) DEVICE DURING ITS USE. IMPEDANCE VALUES WERE MEASURED AND REPORTED FOR EACH CONTACT, WITH SPECIFIC VALUES PROVIDED 0 REFERENCE 1 8539 2 8127 3 7716 4 9417 5 7523 6 7976 7 10418 8 8552 9 7798 10 7633 11 10940 12 8443 13 8841 14 10624 15 8566. TROUBLESHOOTING WAS PERFORMED BY REMOVING THE DISTAL END OF THE LEADS FROM THE IMPLANTABLE PULSE GENERATOR, WIPING AND DRYING THEM, AND THEN RECONNECTING; HOWEVER, NO CHANGE WAS OBSERVED. CLINICAL OBSERVATION INDICATED NO CHANGE IN RECOVERY WHEN THE PATIENT WAS LYING SUPINE. APPROXIMATELY 10CC SALINE WAS USED IN THE EPIDURAL SPACE WITH LOSS OF RESISTANCE DURING LEAD PLACEMENT INSTEAD OF STERILE WATER. NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR DEATHS WERE REPORTED. NO ACTION WAS TAKEN, AND THE ISSUE IS ONGOING. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742460 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000984687

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male "SEE H11."