BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 22014169 · Received May 13, 2025

    Report

    Report Number
    3004209178-2025-08278
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    January 1, 2019
    Report Date
    June 24, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3889-33 LOT# UNKNOWN IMPLANTED: (B)(6) 2019 PRODUCT TYPE LEAD. 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

    CONTINUATION OF D10: PRODUCT ID 3889-33, LOT# UNKNOWN, IMPLANTED: (B)(6) 2019, PRODUCT TYPE LEAD. 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

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME INTERSTIM; PRODUCT ID 3889-33 (LOT: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2019. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE FOLLOW UP LETTER WAS INCORRECT AND DID NOT APPLY. THEY EXPLAINED THAT AN IMAGING FACILITY SENT THIS IN ERROR. THEIR FRACTURED LEAD, FROM 2019, WAS RESOLVED IN 2019. THEY HAD A NEW NEUROSTIMULATOR AND BOTH THE STIMULATOR AND FRACTURED LEAD WERE FULL BODY MRI COMPATIBLE. THE MANUFACTURER HAD VERBIAGE IN THE MRI SECTION STATING THAT THEIR DEVICE WAS FULL BODY MRI COMPATIBLE. THEY HAD 2 MRI'S IN THE LAST YEAR WITHOUT INCIDENT. THE ORIGINAL SURGEON HAD WRITTEN AND EXPLAINED THAT THEIR LEAD WAS 100% FULL BODY MRI SAFE. THE IMAGING FACILITY REFUSED TO DO THE MRI. THEY HAD NO ISSUE WITH THEIR DEVICE OR THEIR DOCTOR. THERE WAS NOTHING TO REPORT. THEY NOTED THAT THE MANUFACTURER WAS AWARE OF THEIR FRACTURED LEAD IN 2019 SINCE THEY WERE PRESENT IN THE OPERATING ROOM. THERE WAS OLD VERBIAGE IN THE MRI DEVICE STATING THEY HAD A FRACTURED LEAD. STU DIES WERE DONE IN THE LAST 5 YEARS THAT DETERMINED THE OLD, EMBEDDED, UNUSED, UNATTACHED FRACTURED LEAD WAS FULL BODY MRI SAFE. IN 2024, A MANUFACTURING TECHNICIAN CHANGED THE VERBIAGE TO REFLECT THE SAFETY OF A FULL BODY MRI. AN IMAGING CENTER APPROVED THE MRI, BUT WHEN THEY GOT THERE, THE TECH REFUSED TO DO IT. THE PATIENT SHOWED THEM 2 LETTERS FROM THE SURGEON STATING THAT THE FRACTURED LEAD WAS FULL BODY MRI SAFE, BUT THE TECH STILL REFUSED TO DO THE MRI. THE PATIENT PUT THE DEVICE IN MRI MODE AND LET THEM READ THE MESSAGE STATING THE DEVICE WAS FULL BODY MRI SAFE. THE PATIENT NOTED THEY WERE VERY HONEST ABOUT THE FRACTURED LEAD. IT WAS IN THEIR RECORDS. THEY NOTED THAT THEY DON'T HAVE A COMPLAINT AGAINST THE MANUFACTURER, THEIR DEVICE, OR THEIR SURGEON. THIS MATTER WAS RESOLVED UNTIL LAST FRIDAY WHEN A TECH REFUSED TO DO THE MRI AFTER IT HAD BEEN APPROVED. ADDITIONAL INFORMATION WAS RECEIVED FROM AN MRI TECH WHO STATED THAT THE PATIENT HAD A FRACTURED LEAD. THE PATIENT'S MEDICAL CHART STATES THEY TOLD A HEALTHCARE PROVIDER (HCP) THAT THE PHYSICIAN COULD REMOVE THE INS (PREVIOUS ONE), AS IT WAS TOO PAINFUL AND THE URINARY SYMPTOMS HAD RETURNED. THE CALLER BELIEVED THIS ALL OCCURRED ON (B)(6) 2023. THEY WERE NOT SURE WHEN THE MANUFACTURING REPRESENTATIVES WERE NOTIFIED, BUT STATED A REP WAS PRESENT AT A PREVIOUS MRI THE PATIENT HAD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT "HONESTLY, THERE IS NO ISSUE."

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE PATIENT HAD A "FRAGMENTED" LEAD LEFT IMPLANTED IN ADDITION TO THE ACTIVE SYSTEM PLACED IN 2023. THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO CONFIRM MODEL NUMBER OF LEAD AND STATED THE PATIENT REPORTED THIS LEAD BROKE IN 2019 AND THAT WAS WHY THEY HAD A NEW SYSTEM PLACED. HCP NOTED THE PATIENT SAID THEY HAD A LETTER REGARDING THE FRAGMENT THAT THEY RECEIVED AND THAT IT WAS "TESTED AND OK FOR MRI." THE HCP WAS INQUIRING IF THE PATIENT WAS ELIGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879993 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention "SEE H11...."| "SEE H11...."| SEE H11...