BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 22344507 · Received June 27, 2025

    Report

    Report Number
    3004209178-2025-11026
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    August 27, 2024
    Report Date
    August 21, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000699796
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    H3: THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE SURGEON IMPLANTED THE NEUROMODULATOR (INS) CONNECTED TO LEAD. THE PROGRAMMING OF THE SYSTEM WAS CARRIED OUT WITH THE PROGRAMMER. THE PROBLEM IS THAT A FEW WEEKS AFTER IMPLANTATION, THE PATIENT REALIZED THAT THE STIMULATION AMPLITUDE WAS RETURNING TO 0. THE PATIENT HAS RESPECTED ALL THE RECOMMENDATIONS FOR USE GIVEN BY THE SURGEON AND USES THE PROGRAMMER PERFECTLY. THE SURGEON SAW THE PATIENT IN CONSULTATION TO REPROGRAM AND PUT BACK A CORRECT STIMULATION. A FEW DAYS LATER THE AMPLITUDE WAS AGAIN AT 0. IT WAS NEVER POSSIBLE TO MAINTAIN STABLE PROGRAMMING. THE SURGEON THEREFORE CHANGED THE NEUROMODULATOR BY KEEPING THE ELECTRODE WHICH DID NOT HAVE AN ANOMALY. A NEW INS WAS IMPLANTED. ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938400 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00763000699796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention