BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1864333 · Received October 7, 2010

    Report

    Report Number
    3007566237-2010-07714
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    January 1, 2009
    Report Date
    August 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A "DYSFUNCTION OF THE DEVICE" AFTER THE PATIENT STARTED WORKING AROUND HIGH MAGNETIC FIELDS. THE DEVICE WAS REPLACED. FOR INFORMATION ABOUT EVENTS FOLLOWING REPLACEMENT, REFER TO MFR REPORT # 9614453-2010-07716.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC NEUROMODULATION 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention