BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 19318673 · Received May 15, 2024

    Report

    Report Number
    3004209178-2024-10982
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    November 1, 2018
    Report Date
    May 15, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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: 3093-28 (LOT: V181439); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2008; 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 UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT CALLED TO INQUIRE ABOUT MRI COMPATIBILITY AND THE REPORTED THAT THE  INS WAS REMOVED IN (B)(6) 2018 BECAUSE THEIR HEALTH CARE PROVIDER (HCP) HAD GIVEN THE PATIENT ANOTHER THERAPY ROUTE TO TAKE, AND THE PATIENT OPTED TO GO WITH THAT. THE PATIENT STATED THEY WERE INITIALLY TOLD BY THEIR HEALTH CARE PROVIDER (HCP) THAT EVERYTHING HAD BEEN REMOVED; HOWEVER, A FEW DAYS AFTER THE REMOVAL, THE PATIENT HAD AN X-RAY DONE BY AN MRI FACILITY, AND THE FACILITY TOLD THE PATIENT THERE WAS A FRAGMENT LEFT BEHIND SO THE MRI WOULD NOT BE ABLE TO BE DONE. THE PATIENT STATED THEY TALKED TO THEIR HCP ABOUT THE FRAGMENT, AND THE HCP TOLD THE PATIENT THAT THEY WEREN'T A "SPINAL SURGEON" AND TOLD THE PATIENT AT THE TIME THEY WEREN'T "GOING TO DIG AROUND IN YOUR SPINE" TO REMOVE IT, SO IT WAS LEFT BEHIND. THE PATIENT STATED THE HCP TOLD THE PATIENT THEY THOUGHT THE LEAD MIGHT HAVE BROKEN. THE PATIENT STATED THEY WERE ABLE TO SUCCESSFULLY HAVE A HEAD/BRAIN SCAN AT ANOTHER CLINIC, BUT NOW THEY WERE IN NEED OF AN MRI OF THEIR SINUSES, AND THE CLINIC WANTED THE PATIENT'S DEVICE INFORMATION. PATIENT SERVICES REVIEWED DEVICE REGISTRATION INFORMATION WITH THE PATIENT AS WELL AS REVIEWED MRI GUIDELINES WITH THE PATIENT. PATIENT SERVICES REDIRECTED THE PATIENT TO HAVE THEIR PHYSICIAN ORDER THE MRI OR THE MRI FACILITY CALL TECHNICAL SERVICES TO DISCUSS THE NEW MRI LABELING FOR LEAD FRAGMENTS. THE PATIENT STATED THEY WOULD HAVE THE HCP/CLINIC CALL TECHNICAL SERVICES AND STATED THEY ASSUMED THEY WOULD NEED TO GET AN X-RAY TO DETERMINE LEAD FRAGMENT INFORMATION. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357628 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention SEE H11...