BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3007566237-2013-01564

    MDR report key: 3102557 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01564
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE TRIAL INFUSION WAS STOPPED UNTIL THE PATIENT RECOVERED. THE PATIENT RECOVERED LATER THAT SAME DAY. THE TRIAL CONTINUED WITH A DOSE OF 50 MCG/DAY. THE PATIENT WENT INTO SURGERY AND THE PUMP AND CATHETER WERE IMPLANTED. THE PATIENT WAS RECEIVING INTRATHECAL BACLOFEN THERAPY AND WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNDERGOING A CONTINUOUS 2 DAY TRIAL, WITH A PLANNED IMPLANT FOR THE DAY OF REPORT, BUT THE PATIENT WAS FOUND TO BE RUNNING A LOW GRADE FEVER. THE HEALTHCARE PROVIDER (HCP) ASPIRATED THE CATHETER AND TOOK A CEREBROSPINAL FLUID (CSF) SAMPLE AND THEN RESTARTED THE PUMP. FOLLOWING THE RESTART OF THE PUMP, THE REPORTER INDICATED THE PATIENT "SEEMED TO BE OVERDOSED," SO THE HCP STOPPED THE INFUSION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203625 LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention