BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMER

    MDR report key: 821098 · Received February 23, 2007

    Report

    Report Number
    2182207-2007-00678
    Event Type
    Injury
    Date Received
    February 23, 2007
    Date of Event
    February 15, 2007
    Report Date
    February 16, 2007
    Manufacturer
    NEUROLOGICAL DIVISION, METRONIC, INC.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER'S REPRESENTATIVE REPORTED THAT DUE TO A MISCOMMUNICATION BETWEEN HEALTH CARE PROVIDERS REGARDING STARTING DOSE WITH THE NEW PUMP, THE PATIENT WAS OVERDOSED FOLLOWING CATHETER AND PUMP REPLACEMENT. THE PATIENT PREVIOUSLY HAD BEEN EXPERIENCING LACK OF EFFECT AND HAD UNDERGONE CATHETER DYE STUDY WITH INCONCLUSIVE RESULTS. DUE TO THE PATIENT'S SYMPTOMS, HE WAS TAKEN TO SURGERY FOR CATHETER REPLACEMENT AT WHICH TIME IT WAS ELECTED TO ALSO REPLACE THE PUMP. FOLLOWING THE SURGERY AND NEW PUMP PROGRAMMING, THE PATIENT BECAME UNAROUSABLE. THE PUMP CONTAINED LIORESAL 2000 MCG/ML; IT IS UNK WHAT DOSAGE WAS PROGRAMMED. THE PUMP AND CATHETER WERE ASPIRATED AND THE PUMP WAS REFILLED WITH LIORESAL 500 MCG/ML WITH A REDUCED DAILY DOSE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMER LKK LKK NEUROLOGICAL DIVISION, METRONIC, INC. PROGRAMMER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R IMPLANTABLE INFUSION PUMP MODEL 8637| CATHETER MODEL 8709 LOT# N092621003 IMPLANTED| LOT# NGV403392H IMPLANTED| EXPLANTED| EXPLANTED