BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3932009 · Received July 14, 2014

    Report

    Report Number
    3007566237-2014-01950
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOUR DAYS PRIOR TO THE DATE OF THIS REPORT, IT WAS INDICATED THE TRIAL PATIENT HAD A TEMPERATURE. THERE WAS MINOR BLEEDING AT THE LEAD SITE AND THERE WAS A ¿2-INCH CIRCLE¿ ON THEIR SHEET WHEN THEY WOKE UP THAT MORNING. AS OF THE DATE OF THIS REPORT, IT WAS NOTED THE PATIENT HAD AN INFECTION AND IT WAS DUE TO ANESTHESIA. THE TEST BOX WAS OFF. THEY CALLED THE DOCTOR¿S OFFICE AND WENT TO THE EMERGENCY ROOM. THE PATIENT WAS THEN ADMITTED THE WEEKEND PRIOR TO THE DATE OF THIS REPORT. TWO DAYS LATER, IT WAS NOTED THE PATIENT WAS HOME AND HAD STARTED THEIR TEST ON PROGRAM 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409276 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R