BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2191105 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-05888
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    December 1, 2010
    Report Date
    July 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010 IT WAS REPORTED THAT THE PT EXPERIENCED AN OVERSTIMULATION SENSATION WHEN SITTING DOWN. THE PT WAS GOING TO ADJUST STIMULATION TO STAY COMFORTABLE DURING POSITIONAL CHANGES, AND REPORTED RECEIVING GOOD THERAPY. ON (B)(6) 2011 IT WAS REPORTED THAT THE PT WAS FEELING STIMULATION IN THE WRONG LOCATION. THE PT FELT STIMULATION IN HER FOOT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. ADDITIONAL INFO RECEIVED REPORTED THAT THE MOBILITY OF THE NEUROSTIMULATOR HAD CAUSED STIMULATION IN THE WRONG LOCATION, AS IT HAD ROTATED 90 DEGREES. ON (B)(6) 2011 THE NEUROSTIMULATOR WAS REVISED IN THE SAME SITE. ON (B)(6) 2011 THE DEVICE WAS MOVED FROM THE RIGHT SIDE TO THE LEFT SIDE. IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PT INCURRED NO INJURY, AND WAS LAST SEEN IN HER PHYSICIAN'S OFFICE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANTED:| LEAD: MODEL 3889, LOT# V505195| PROGRAMMER: MODEL 3037, LOT# NJD111481N| EXTENSION: MODEL 3095, LOT# NAH045464V| EXPLANTED:| IMPLANTED:| EXPLANTED: