BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1061624 · Received June 17, 2008

    Report

    Report Number
    3004209178-2008-03307
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Report Date
    May 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION TURNS OFF AT VARIOUS TIME. THE PT IS ABLE TO TURN THE THERAPY BACK ON WITH HIS PT PROGRAMMER. THE PT'S DEVICES WERE INTERROGATED IN 2008. NO PT INJURY WAS REPORTED. IN THE FOLLOWING MONTH, IT WAS REPORTED THE PT WAS FOUND ON THE FLOOR AFTER THE DEVICE HAD TURNED OFF. THE PT WAS SEEN BY THE PHYSICIANS ASSISTANT; THE PROBLEM COULD NOT BE DETERMINED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3389| EXPLANTED:| LEFT DEEP BRAIN STIMULATION SYSTEM| EXPLANTED:| EXTENSION: MODEL 7482