BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 22529540 · Received July 17, 2025

    Report

    Report Number
    3004209178-2025-12192
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 17, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PATIENT WHO WAS BEING TREATED FOR PAIN MANAGEMENT WITH AN IMPLANTABLE NEUROSTIMULATOR (IMPLANTABLE NEUROSTI MULATOR 97714 RESTORE SENSOR AND LEAD 977C165 SPECIFY SURESCAN) EXPERIENCED A RETURN OF PAIN AND A LOSS OF EFFECTIVENESS OF THE DEVICE IN CONTROLLING PAIN. THE PATIENT STATED THAT THE DEVICE WAS NO LONGER HELPING WITH PAIN AND REFUSED TO ALLOW REPROGRAMMING OR ADJ USTMENT OF THE SETTINGS, DESPITE RECOMMENDATIONS FROM THE PHYSICIAN. THE PATIENT REQUESTED REMOVAL OF THE DEVICE. BOTH THE LEAD AND BATTERY WERE REMOVED. THE ISSUE WAS RESOLVED FOLLOWING DEVICE REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. SEE GENERAL TEXT FOR OMITTED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664755 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention