BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1003443 · Received February 21, 2008

    Report

    Report Number
    2182207-2008-00831
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PT HAD A RETURN OF SYMPTOMS WHILE AT HOME (SYMPTOMS NOT SPECIFIED). IN 2008, THE PUMP WAS INTERROGATED IN THE CLINIC; PUMP LOGS SHOWED THAT THE CRITICAL ALARM WAS OCCURRING, AND THE PUMP WAS IN THE MINIMUM RATE INFUSION MODE. THE PUMP HAD GONE INTO SAFE STATE MODE ON FOUR DAYS EARLIER. NO OTHER EVENTS WERE NOTED IN THE PUMP LOGS. IT WAS THE FIRST TIME THE EVENT OCCURRED. THE PT WAS IN THE NORMAL REFILL CYCLE AND HADN'T HAD A MAGNETIC RESONANCE IMAGING. THE PUMP WAS USED TO DELIVER DILAUDID 10 MG/ML. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# N056052023| EXPLANTED: