BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3260138 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-12647
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V940070, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT URINATED A VERY YELLOW COLOR AND IT HAD A BAD ODOR. IT WAS NOTED THAT THE PATIENT HAD A YEAST INFECTION ALL THE TIME. IT WAS NOTED THAT THE PATIENT WAS NOT HAVING ALL THESE ISSUES BEFORE THE IMPLANT. IT WAS NOTED THAT THE PATIENT WAS TOLD BY A HEALTH CARE PROVIDER (HCP) THAT SHE HAD TERRIBLE INFECTIONS. IT WAS NOTED THAT THE PATIENT STATED THAT SHE HAD A LYMPH NODE IN HER NECK THAT WAS SWOLLEN DUE TO THE INFECTION. IT WAS NOTED THAT THE PATIENT KEPT CALLING FOR ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT CURRENTLY TOOK AMOXICILLIN FOR BLADDER INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359829 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention