BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2774303 · Received October 5, 2012

    Report

    Report Number
    3004209178-2012-08929
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 10, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V801866, IMPLANTED: (B)(6) 2011, 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 PATIENT HAD PAIN IN THE ABDOMINAL AREA. THE PAIN STARTED ON THE MORNING OF THE DATE OF THIS REPORT. PATIENT WAS HOSPITALIZED FOR ABDOMINAL PAIN, URINARY TRACT INFECTION AND OTHER MEDICAL ISSUES THAT WERE NOT RELATED TO THE DEVICE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THERE WAS NO KNOWN FALLS OR TRAUMA. IT WAS NOTED THAT PATIENT HAD "THIS SENSATION" BEFORE BUT NO DETAILS WERE AVAILABLE ABOUT "THIS." THEN THEY CHECKED THE NEUROSTIMULATOR WITH PATIENT PROGRAMMER. INITIALLY, THERE WAS NO TELEMETRY. THE STIMULATOR WAS TURNED DOWN FROM 3 VOLT TO 0 VOLT. PATIENT WAS STILL HAVING PAIN WITH STIMULATION AT 0 VOLT.

    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 Hospitalization