BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 2244060 · Received August 24, 2011

    Report

    Report Number
    3007566237-2011-06788
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P86004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS OPENED ON A BACK TABLE IN THE OPERATING ROOM (OR). WHEN THE INNER PEEL PACK WAS OPENED, BUT NOT TAKEN OUT OF THE TRAY, AN APPROXIMATE 2.5 CM BEND AT THE DISTAL END OF THE CATHETER WAS NOTED. THE RPTR STATED IT WAS NOT DAMAGED BY OPENING THE PACKAGE; RATHER IT CAME OUT OF PACKAGE ALREADY BENT. A SECOND CATHETER WAS USED FOR IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION 8709SC N274846007

    Patients

    Seq Age Sex Outcome Treatment
    1