BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM X

    MDR report key: 21514377 · Received March 4, 2025

    Report

    Report Number
    3004209178-2025-03922
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 4, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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, URGE INCONTINENCE. IT WAS REPORTED THAT THEY WERE IMPLANTED WITH THE PERMANENT DEVICE TODAY AND NOW THAT THEY WERE HOME, THEY WERE SEEING THAT THE THERAPY WAS NOT HELPING WITH THEIR BLADDER SYMPTOMS. PATIENT SAID THEY KEPT PEEING AND THEIR PADS WERE WET. PATIENT DIDN'T FEEL STIMULATION AND WANTED TO INCREASE STIMULATION BUT WASN'T ABLE TO GET IMPLANT CONNECTED. DURING CALL PS WALKED PATIENT THROUGH CONNECT WITH INTERSTIM X THERAPY APP, THERAPY WAS OFF. PATIENT SAID AT THE HOSPITAL THE THERAPY WAS ON AND SAID THEY DIDN'T KNOW WHAT THEY HAD DONE WRONG. PT TURNED THERAPY BACK ON AND INCREASED STIMULATION TO WHERE THEY COULD FEEL STIMULATION. PS EMAILED DRS TO ENSURE PERMANENT DEVICE WAS BEING REGISTERED. PS ASKED FOR MANAGING HCP INFO AND PATIENT WAS HARD TO UNDERSTAND EVEN WHEN PATIENT REPEATED THEMSELVES. PS UNSURE OF SPELLING AND WAS NOT GOING TO ASK PATIENT A THIRD TIME FOR SPELLING AS PATIENT WAS BECOMING ESCALATED AND SAID THIS WHOLE PROCESS WAS GIVING THEM A HEADACHE. PATIENT CALLED AGAIN AND REPORTED THEY USED 9 PADS LAST NIGHT AND TODAY AND REPORTED THERAPY IS NOT WORKING. PATIENT STATED THEY THINK THERAPY NEEDS TO BE INCREASED. REVIEWED THERAPY OVERVIEW AND HOW TO CONNECT WITH PATIENT'S IMPLANT TO INCREASE STIMULATION. PATIENT MADE A COMMENT WHILE TRYING TO CONNECT WITH THEIR IMPLANT THAT THEY HAVE A "HARD TIME DOING THIS". PATIENT SUCCESSFULLY CONNECTED WITH IMPLANT ON THE CALL AND CONFIRMED THERAPY WAS ON. PATIENT INCREASED STIMULATION. PATIENT INQUIRED IF THEY SHOULD INCREASE STIMULATION UNTIL IT IS "SHOCKING" THEM. AGENT REVIEWED STIMULATION OVERVIEW. PATIENT CLARIFIED BY THIS THEY ARE NOT FEELING SHOCKING SENSATION AND DESCRIBED FEELING OF STIMULATION AS "THROBBING". PATIENT CONFIRMED FEELING STIMULATION COMPLETELY COMFORTABLE AND WANTED TO LEAVE STIM AT THAT LEVEL. WHEN ASKED FOR EVENT DATE, PATIENT STATED THEY CALLED YESTERDAY BECAUSE THEY HAD A LOT OF ACCIDENTS AND AGAIN LAST NIGHT. PATIENT STATED THEY INCREASED STIMULATION AND REPORTED THEN "ALL THIS PROFANITY HAPPENED LAST NIGHT". PATIENT WILL MAINTAIN STIMULATION LEVEL AND WILL CONTINUE TO TRACK SYMPTOMS. REDIRECT TO DOCTOR IF ISSUE PERSISTS. AGENT HAD A DIFFICULT TIME HEARING PATIENT THROUGHOUT THE CALL DUE TO POOR PHONE CONNECTION AND MADE BEST ATTEMPT TO COLLECT/DOCUMENT ALL RELEVANT EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696683 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female