BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 14103802 · Received April 13, 2022

    Report

    Report Number
    3004209178-2022-04670
    Event Type
    Injury
    Date Received
    April 13, 2022
    Report Date
    April 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V881399, IMPLANTED: (B)(6)2012, EXPLANTED: (B)(6) 2021,PRODUCT TYPE :LEAD, UBD: 21-NOV-2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM 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 THEIR PRIOR INS WAS REMOVED BECAUSE IT WASN'T WORKING (PATIENT SERVICES DID NOT ASK EVENT DATE FOR "WASN'T WORKING" BECAUSE OF THE CONFUSING NATURE OF THE CALL) AND WHEN THEY TOOK IT OUT THEY COULD NOT TAKE IT COMPLETELY OUT BECAUSE ONE PART OF IT IS IMBEDDED ON THEIR SCIATIC NERVE SO THEY CAN'T TAKE IT OUT AND NOW PARALYSIS IS SETTING IN. THE PT SAID THEY ARE BEING TOLD THEY ARE GOING TO END UP IN A WHEELCHAIR. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE PATIENT SAID IT WAS LAST YEAR IN (B)(6) 2020, THEY COULD NOT TAKE OUT THE PART THAT WAS EMBEDDED IN THEIR SCIATIC AND THE PARALYSIS DUE TO THE SCIATIC STARTED 6 MONTHS FROM (B)(6) SO (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654332 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention