BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM X

    MDR report key: 21231541 · Received January 24, 2025

    Report

    Report Number
    3004209178-2025-01468
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 24, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT WHEN THE PATIENT WAS WITH THE MRI TECHNICIAN THEY WERE ASKED TO PUT THE DEVICE INTO MRI MODE AND WHEN THEY DID THAT THEY FELT A LITTLE ELECTRIC SHOCK. THE PATIENT STATED THEY FELT THE SHOCK WHEN PUTTING THE DEVICE INTO MRI MODE. THE PATIENT STATED THEY PUT IT UP TO 0.5 AND IT HAD ALWAYS WORKED FOR THEM BUT THEY STILL FELT THE ELECTRIC SHOCK OR ELECTRIC TOUCH IN THEIR FINGERTIPS AND DOWN THEIR LEG. THE PATIENT WAS ADVISED THAT THE STIMULATION COULD BE TOO HIGH IF THEY WERE FEELING PAIN FROM THE STIMULATION. THE PATIENT WAS ASKED IF THEY HAD ANY FALLS OR TRAUMA TO THE AREA AND THE PATIENT STATED NO BUT WHEN THEY SET IT UP THEY FELT LIKE SOMETHING WAS SHAKING DOWN LIKE A FULL VIBRATION SENSATION DOWN. THE PATIENT STATED THAT WHEN THEY TURNED THE STIMULATION OFF THE SENSATION IN THEIR FINGERTIPS WENT AWAY. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE. THE PATIENT STATED THE MRI TECH WAS ASKING FOR AN MRI ELIGIBILITY FORM. MRI GUIDELINES WERE REVIEWED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018214 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female