BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMER

    MDR report key: 819978 · Received February 21, 2007

    Report

    Report Number
    2182207-2007-00638
    Event Type
    Injury
    Date Received
    February 21, 2007
    Date of Event
    January 31, 2007
    Report Date
    February 8, 2007
    Manufacturer
    NEUROLOGICAL DIVISION, METRONIC, INC.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER'S REPRESENTATIVE REPORTED THAT FOLLOWING REPROGRAMMING THE PUMP ON 1/31/2007 TO COMPLEX CONTINUOUS MODE, THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS OF LETHARGY AND RESPIRATORY DEPRESSION. THE REPORTER INDICATED THAT THE PREVIOUS DAY THE PUMP WAS PROGRAMMED INCORRECTLY TO CONTINUOUSLY DELIVER COMPOUNDED BACLOFEN 253 MCG EVERY 31 MINUTES. THE PATIENT HAD PREVIOUSLY BEEN PROGRAMMED IN PERIODIC BOLUS MODE WITH 4 BOLUSES PER DAY. THE HCP CHANGED TO COMPLEX CONTINUOUS MODE AS HE WANTED TO DELIVER 4 BOLUSES/DAY WITH LESS MEDICATION IN THE AM AND MORE IN THE PM, BUT DID NOT PROGRAM SMALLER DOSES WITH INTERVAL PERIODS BETWEEN LARGER DOSES THE PATIENT WAS IN THE EMERGENCY ROOM AND WAS INTUBATED AT THE TIME OF THIS REPORT. THE PATIENT WAS GIVEN SUCCINYLCHOLINE PRIOR TO INTUBATION SO THEY WERE UNABLE TO GIVE PHYSOSTIGMINE DUE TO CONCERNS OF FURTHER RESPIRATORY DEPRESSIVE EFFECTS. NO DEVICE TROUBLESHOOTING WAS PERFORMED. NO OTHER TREATMENT PROVIDED TO THE PATIENT WAS REPORTED. THE PATIENT HAS RECOVERED WITHOUT SEQUELA AND IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R CATHETER MODEL 8709AA LOT# J11729R28| EXPLANTED:| LOT# NGH041102R| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 8627L18