BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL

    MDR report key: 1993749 · Received January 13, 2011

    Report

    Report Number
    3007566237-2011-00361
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT THE LEAD BROKE. DETAILS WERE NOT PROVIDED. THE PT, DEVICE, AND PHYSICIAN INFO WERE UNKNOWN. FURTHER FOLLOW-UP WAS NOT POSSIBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPLANTED:| EXPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNKNOWN