BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2061127 · Received March 7, 2011

    Report

    Report Number
    3007566237-2011-01681
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    December 27, 2010
    Report Date
    February 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING SURGICAL PLACEMENT OF THE INTRATHECAL CATHETER, THE GUIDEWIRE WAS REMOVED TO CONFIRM THE FREE-FLOW OF SPINAL FLUID. A SUTURE WAS PLACED AND AS THE NEEDLE WAS WITHDRAWN, IT WAS NOTED THE CATHETER WAS SHEARED. IT WAS POSSIBLE THE CATHETER WAS KINKED AT THE TIP OF THE NEEDLE AND THIS RESULTED IN ITS SHEARING. THE PRESENCE OF SCAR TISSUE IN THE AREA OF CATHETER PLACEMENT MAY HAVE AFFECTED THE FORCE NECESSARY TO WITHDRAW THE NEEDLE FROM THE INTRATHECAL COMPARTMENT. THE EPIDURAL NEEDLE WAS IN THE PATIENT'S BODY AND THE SHEARING OF THE CATHETER APPEARED TO HAVE OCCURRED AT THE TIP OF THE NEEDLE. APPROXIMATELY 15 CM OF THE CATHETER REMAINED IN THE PATIENT; ATTEMPTS TO REMOVE IT WERE UNSUCCESSFUL. ANOTHER CATHETER WAS USED AND PLACED BETWEEN L1 AND L2 OF THE SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNK LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N260168002| IMPLANTED: