BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1040366 · Received May 7, 2008

    Report

    Report Number
    3004209178-2008-02453
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PT'S FIRST REFILL, THE EXPECTED VOLUME WAS 5 MLS; HOWEVER, THE INITIAL 20 MLS REMAINED IN THE PUMP. THE PUMP WAS REFILLED AND REPROGRAMMED. THE HCP PLANNED TO REVIEW THE PT AGAIN IN ONE MONTH. THE PUMP WAS BEING USED FOR SPASTICITY THERAPY; THE DRUG WAS NOT SPECIFIED. NO PT SYMPTOMS WERE REPORTED. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1