BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4932686 · Received July 22, 2015

    Report

    Report Number
    3007566237-2015-02057
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED THE TRIAL TWO WEEKS AGO AND THAT AFTER 2-3 DAYS OF THE TRIAL THE LEADS MOVED. AFTER THE 4TH DAY THE PATIENT REPORTEDLY FELT NUMBNESS IN HER LEG (THIS WAS NOT PERMANENT AND WAS RESOLVED WHEN THE DEVICE WAS TURNED OFF). ON THE 5TH DAY THE PATIENT WOKE UP AND DID NOT FEEL STIMULATION. THE PATIENT HAD COLON ISSUES AND HAD CONSTIPATION THROUGHOUT THE DURATION OF THE TRIAL. THE TRIAL REPORTEDLY HELPED THE PATIENT'S SYMPTOMS THE LAST 3-4 DAYS OF THE TRIAL. ADDITIONAL INFORMATION REPORTED THAT THIS WAS NOT DUE TO THE TRIAL OR ANY PRODUCTS. THE PATIENT HAD A CONCLUSIVE TRIAL AND WENT ON FOR PERMANENT IMPLANT AND WAS DOING GREAT AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477812 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1