BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3709624 · Received March 28, 2014

    Report

    Report Number
    3004209178-2014-05264
    Event Type
    Injury
    Date Received
    March 28, 2014
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VAGINAL YEAST INFECTION WITH SYMPTOMS OF VOMITING, CHILLS, VAGINAL DISCHARGE, AND ITCHING REPORTED. THE ETIOLOGY OF THE EVENT WAS REPORTED AS ¿NEW ILLNESS, INJURY¿. THE PATIENT WAS TREATED WITH TERAZOL (7 QHS FOR 7 DAYS) AND ¿MAGIC BUTT CREAM¿. THE OUTCOME OF THE EVENT WAS REPORTED, AS OF (B)(6) 2011, AS RESOLVED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186378 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention