BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3675435 · Received March 12, 2014

    Report

    Report Number
    3004209178-2014-04338
    Event Type
    Injury
    Date Received
    March 12, 2014
    Report Date
    February 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V890309, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS VERIFIED THAT INS WAS TURNED OFF. THE PATIENT WAS IN PROGRAM #3 AT 0.40, CALLER DECREASED TO 0.00. THE PATIENT HAD BEEN HAVING CHRONIC VAGINAL INFECTION FOR OVER 2 YEARS. THE PATIENT WAS GOING TO BE EVALUATED IN MARCH, FOR TESTING AND HCP (HEALTHCARE PROVIDER) WANTED IMPLANT TO BE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148995 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention