BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1190855 · Received July 29, 2008

    Report

    Report Number
    6000032-2008-04476
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED MINOR STIMULATION IN THE POCKET, WHILE USING AN ORBITAL SANDER OR A DRILL BENCH. THE NEUROSTIMULATOR WAS TURNED OFF. ADDITIONAL INFORMATION 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 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION: MODEL 7495-51| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7434| EXPLANTED:| LEAD: MODEL 3587A