BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 21653302 · Received March 20, 2025

    Report

    Report Number
    3004209178-2025-04959
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    May 13, 2024
    Report Date
    March 20, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3889-28 LOT# V138915 IMPLANTED: (B)(6) 2009: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(6), UBD: 24-JUL-2012, UDI#: (B)(4) 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 GASTROINTESTINAL/PELVIC FLOOR THERAPY AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THEY WENT TO THE DOCTOR YESTERDAY ((B)(6) 2025) AND THEY TOLD THE PATIENT THEY WANTED TO SEND THE PATIENT FOR AN MRI OF THEIR LOWER LUMBAR SPINE AND THE PATIENT HAD WANTED TO INQUIRE ABOUT MRI COMPATIBILITY WITH PATIENT SERVICES. PATIENT SERVICES WALKED THE PATIENT THROUGH CONNECTING TO THEIR IMPLANT SETTINGS AND ACTIVATING MRI MODE. THE MRI MODE SHOWED THAT THEY WERE NOT ELIGIBLE FOR A FULL BODY SCAN DUE TO AN ABANDONED COMPONENT (MRI CODE 0151310). PATIENT SERVICES REVIEWED THE MEANING OF THE MESSAGE WITH THE PATIENT. THE PATIENT STATED THAT WHEN THEY GOT THEIR MOST CURRENT IMPLANT IN (B)(6) 2024, THEY WERE TOLD THAT THEIR HEALTHCARE PROVIDER (HCP) HAD TRIED TO GET THEIR PREVIOUS LEAD REMOVED BUT THEY WERE UNABLE TO ENTIRELY REMOVE IT SO THERE WAS A SMALL FRAGMENT LEFT FROM THEIR PREVIOUS SYSTEM. THE PATIENT STATED THEY WERE HALF SEDAT ED WHEN THEY WERE TOLD THIS AFTER COMING OUT OF THE PROCEDURE AND THAT THE ATTENDING HEALTHCARE PROVIDER (HCP) HAD TOLD THEM THAT THEY HAD TAKEN IT OUT BUT IT WAS A SMALL PIECE STILL LEFT AND THAT FROM WHAT THE HEALTHCARE PROVIDER SAID, THEY DIDN'T WANT TO DO ANYTHING FURTHER WITH IT BECAUSE IT WAS SITTING TOO CLOSE TO THE PATIENT'S SPINE/THE LEAD FRAGMENT AND SPINE WERE TOO CLOSE TOGETHER SO THEY DIDN'T REMOVE IT. THE PATIENT STATED AS THERE WERE THINGS AFTER THE PROCEDURE THAT THE HEALTHCARE PROVIDER HAD WANTED TO MONITOR, THE PATIENT HAD ENDED UP STAYING OVERNIGHT AT THE HOSPITAL. THE PATIENT DID NOT SAY ANYTHING MORE ABOUT THE "THINGS THE HCP WANTED TO MONITOR." SERVICES REVIEWED MRI GUIDELINES WITH THE PATIENT AND WALKED THE PATIENT THROUGH DEACTIVATING THEIR MRI MODE AND ENDING THEIR SESSION. THE PATIENT WAS REDIRECTED TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER TO FURTHER DISCUSS THEIR MRI ELIGIBILITY. PATIENT STATED THEY NEEDED THE MRI BECAUSE THEY HAD BEEN "COMPLAINING" OF LOWER BACK PAIN AND THAT THEIR GENERAL PHYSICIAN HAD DONE EVERYTHING ELSE INCLUDING SENDING THE PATIENT TO PHYSICAL THERAPY FOR IT BUT THE PHYSICAL THERAPY DIDN'T RESOLVE THE ISSUE SO THE PHYSICIAN SENT THE PATIENT TO A NEUROLOGIST AND THE NEUROLOGIST HAD WANTED TO DO THE MRI. PATIENT SERVICES ADVISED THE PATIENT TO HAVE THE NEUROLOGIST CALL TECHNICAL SERVICES IF THEY HAD ANY QUESTIONS OR CONCERNS ABOUT THE COMPATIBILITY WITH THE PATIENT'S SYSTEM. AN EMAIL WAS SENT TO THE FIELD BY PATIENT SERVICES TO NOTIFY THEM OF THE SITUATION IN THE EVEN THEY WERENEEDED TO DOUBLE CHECK MRI MODE ELIGIBILITY WITH THE LEAD FRAGMENT. PATIENT TO REACH OUT TO THEIR HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373159 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization "SEE H11...."