BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2983391 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03167
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V926979, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT HAD GOOD SYMPTOM RELIEF UNTIL ABOUT 2 WEEKS PRIOR TO THIS REPORT. IT WAS NOTED THAT THE PATIENT RECENTLY HAD A HIP REPLACEMENT. IT WAS STATED THAT THE PATIENT'S BLADDER WOULD NOT DRAIN AND THAT HER STOMACH WAS "HARD." IT WAS STATED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND ARE WANTING TO CHANGE THE STIMULATION TO SEE IF IT HELPS. IT WAS NOTED THAT THE PATIENT WILL TRY OUT NEW SETTINGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87472 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention