BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1220447 · Received November 4, 2008

    Report

    Report Number
    2182207-2008-07194
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 THAT THE HCP EXPERIENCED DIFFICULTY PLACING THE CATHETER IN A HIGH CERVICAL REGION DUE TO LESIONS IN THE HIGH THORACIC REGION. HE DECIDED TO PULL THE CATHETER OUT AND ABORT THE IMPLANT PROCEDURE. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT APPROXIMATELY 6 CENTIMETERS OF THE CATHETER HAD SHEARED OFF. THE CATHETER FRAGMENT REMAINED IN THE PATIENT. IT WAS BELIEVED THAT THE STYLET MAY HAVE GONE THROUGH THE END OF THE CATHETER AND THE CATHETER WAS SHEARED OFF ON THE TIP OF THE NEEDLE. THE HOSPITAL WOULD NOT RELEASE THE CATHETER FOR ANALYSIS BY THE MANUFACTURER. THE PATIENT WAS REFERRED TO A NEUROSURGEON AND THE SYSTEM WAS IMPLANTED IN 2008. THE PATIENT WAS DOING "FINE" AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention