BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 21483946 · Received February 27, 2025

    Report

    Report Number
    3004209178-2025-03742
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Report Date
    February 27, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    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 FECAL INCONTINENCE AND GAST ROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THEY HAD AN INCONSISTENCY OF RESPONSE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON P080025. IT WAS REPORTED THAT THE THEIR DEVICE WAS PUT IN (B)(6) 2022. SOME CONSISTENT IMPROVEMENT IN BLADDER WAS NOTED, LESS SO IN BOWEL CONTROL. THERE WAS ALWAYS A ZAPPING SENSATION IN THE GROIN THAT WAS UNCOMFORTABLE. THEY SAID THEY WERE TOLD THAT WAS NORMAL. AT THE TWO-YEAR POINT, THEY STARTED TO SEE A DECREASE IN BLADDER CONTROL WITH SOME LEAKAGE. THE PAIN PERSISTED. A MANUFACTURING REPRESENTATIVE(REP) WORKED WITH THEM AND STOPPED THE ZAPPING SENSATION. THIS ALSO HELPED THE LEAKAGE ISSUE TO SOME DEGREE. THERE WERE STILL OCCASIONAL LEAKAGE ISSUES. BOWEL WAS LESS SUCCESSFUL. THE PATIENT STATED THEY WOULD RATE THEIR CURRENT RESPONSE AT 85% URINARY LEAKAGE RELIEF AND ABOUT 60% FOR BOWEL RESPONSE. THESE NUMBERS HAVE BEEN THIS WAY SINCE THE REP CORRECTED THE DISCOMFORT ISSUE. THEY STATED THEY ALSO BELIEVED WORKING WITH A PELVIC FLOOR SPECIALIST HAD GREATLY HELPED MY OVERALL RESPONSE AS WELL AS THE UNIT. I HOPE THIS ANSWERS YOUR QUESTION. (CON): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. ON (B)(6) 2025, THE PATIENT STATED THAT THE DEVICE WAS PUT IN JANUARY 2022. SOME CONSISTENT IMPROVEMENT IN BLADDER WAS NOTED, LESS SO IN BOWEL CONTROL. THERE WAS ALWAYS A ZAPPING SENSATION IN THE GROIN THAT WAS UNCOMFORTABLE AND WAS TOLD THAT WAS NORMAL. AT THE TWO-YEAR POINT, THEY STARTED TO SEE A DECREASE IN BLADDER CONTROL WITH SOME LEAKAGE. THE PAIN PERSISTED. A REP WORKED WITH THEM ANDT STOPPED THE ZAPPING SENSATION. THIS ALSO HELPED THE LEAKAGE ISSUE TO SOME DEGREE. THERE ARE STILL OCCASIONAL LEAKAGE ISSUES. BOWEL IS LESS SUCCESSFUL. THEY WOULD RATE MY CURRENT RESPONSE AT 85% URINARY LEAKAGE RELIEF AND ABOUT 60% FOR BOWEL RESPONSE. THESE NUMBERS HAVE BEEN THIS WAY SINCE THE REP CORRECTED THE DISCOMFORT ISSUE. I ALSO BELIEVE WORKING WITH A PELVIC FLOOR SPECIALIST HAS GREATLY HELPED MY OVERALL RESPONSE AS WELL AS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665386 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female