BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 2191785 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05689
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGE WAS WRONGLY LABELED. THE LABELING ON THE PACKAGING REPORTED MODEL NUMBER 87831SC INSTEAD OF 8731SC. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL CATHETER LKK MEDTRONIC NEUROMODULATION 8731SC 0205138274

    Patients

    Seq Age Sex Outcome Treatment
    1