BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2830970 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10214
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V779495, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FROM THEIR IMPLANTABLE NEUROSTIMULATOR (USING THE RESTROOM MORE) WHICH STARTED ABOUT A MONTH AGO. THE PATIENT MENTIONED THIS TO THEIR HEALTHCARE PROFESSIONAL AT WHICH TIME THEY FOUND OUT THEY HAD A URINARY TRACT INFECTION. IT WAS ALSO NOTED THAT THE PATIENT HAD AN MRI IN MAY 2012 WHEN THEY WERE SICK (SINUS CONCERNS). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME 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