BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2842698 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10656
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V734526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT POST IMPLANT THERE WERE NO LEAKING ISSUES, BUT SINCE THEN HAD "TWO OR THREE" URINARY TRACT INFECTIONS (UTI) WITH URINARY FREQUENCY AND "BURNING." THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2012 AND THE MOST RECENT UTI WAS "CLEARED UP." THE PATIENT NO LONGER HAD ANY "BURNING SENSATION." IT WAS ALSO REPORTED THAT THE PATIENT WAS ABLE TO MAKE ADJUSTMENTS WITH HER PROGRAMMER, BUT AFTER THE STIMULATION SENSATION WENT AWAY. THE PATIENT WAS TO DOCUMENT HER SETTINGS AND SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention