BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 22565251 · Received July 22, 2025

    Report

    Report Number
    3004209178-2025-12462
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SPECIFY; PRODUCT ID: 3998 (LOT: V021560); PRODUCT TYPE: 0200-LEAD; PRODUCT ID: 3708260 (SERIAL: (B)(6); PRODUCT TYPE: 0191-EXTENSION. 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 HIGH IMPEDANCE (OVER 40,000 OHMS) WAS DETECTED DURING IMPEDANCE TESTING. THE DEVICE AND EXTENSIONS WERE NOT COMPATIBLE WITH MAGNETIC RESONANCE IMAGING (MRI), AND THE IMPLANTABLE NEUROSTIMULATOR HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE OLD LEAD, EXTENSIONS, AND BATTERY WERE EXPLANTED AND REPLACED WITH A NEW LEAD AND DEVICE. 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
    944577 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention SEE H11.