BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1926107 · Received November 10, 2010

    Report

    Report Number
    3007566237-2010-09203
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON RETURN FROM A HOLIDAY, PATIENT WENT THROUGH SECURITY AT A GREEK AIRPORT IN WHICH A HAND HELD SECURITY SCANNER WAS PASSED OVER HER NEUROSTIMULATOR. THE PATIENT INDICATED THAT AT THIS POINT SHE COULD NOT STAND UP AND FELT PAIN IN RIGHT BUTTOCK (IMPLANT ON THIS SIDE) AND DOWN THE RIGHT LEG. ON EXAMINATION AT A HOSPITAL, (WEEK COMMENCING (B)(6) 2010) PATIENT DID NOT REPORT ANY TRAUMA OR BACK INJURY. THE PAIN HAD PERSISTED AND THEREFORE THE IMPLANTABLE NEURO STIMULATOR (INS) HAD BEEN SWITCHED OFF TO ASCERTAIN IF INDEED THE PAIN WAS RELATED TO THE IMPLANT OR INDEPENDENT OF THIS. AN X-RAY AT THIS TIME SHOWED NO SIGN OF LEAD MIGRATION. IT WAS NOTED THERE WERE ACTIONS REQUIRED AS A RESULT OF THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR EXTENSION: MODEL 3095, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# UNKNOWN| EXPLANTED:| IMPLANTED: