BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INFUSION CATHETER

    MDR report key: 3122356 · Received May 21, 2013

    Report

    Report Number
    3007566237-2013-01693
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 4000M, LOT# 21281098, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THEY WANTED TO USE THE CHEMOPORT FOR AN ITB-TRIAL. BEFORE THE PHYSICIAN INJECTED A DOSE OF LIORESAL, HE WANTED TO MONITOR THE SYSTEM BY ASPIRATING CEREBROSPINAL FLUID. THE PHYSICIAN COULD NOT ASPIRATE, SO HE DID NOT TRY TO INJECT SOME LIORESAL. A SURGICAL REVISION WAS PERFORMED. A NEW CHEMOPORT AND A NEW SPINAL SEGMENT OF THE CATHETER WERE IMPLANTED. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225100 UNKNOWN INFUSION CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention