BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2201364 · Received August 3, 2011

    Report

    Report Number
    3007566237-2011-06009
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HEALTH CARE PROVIDER (HCP) REPORTED DIFFICULTY ASPIRATING FLUID THROUGH THE CATHETER ACCESS PORT (CAP). THE ASPIRATION WAS BEING ATTEMPTED TO GET A CEREBROSPINAL FLUID (CSF) SAMPLE FOR OTHER PURPOSES. NO FURTHER INFO COULD BE OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN| EXPLANTED:| ACCESSORY: MODEL 8540, LOT# UNKNOWN| EXPLANTED: