BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1180182 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06201
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, FOLLOWING A REVISION IN 2008, DUE TO DEHISCENCE, THE PATIENT'S NEW PUMP SITE ALSO BEGAN TO BREAKDOWN. CULTURES WERE DONE OF THE PUMP AND POCKET SITE BUT THE RESULTS WERE NOT AVAILABLE. THE DECISION WAS MADE TO COMPLETELY REMOVE THE ENTIRE DEVICE SYSTEM. THE PATIENT IS VERY THIN. THE PUMP WAS USED TO DELIVER LIORESAL. THE PATIENT IS NOW BEING MANAGED WITH ORAL MEDICATIONS. THE PATIENT HAS NOT BEEN SEEN BY THE HCP SINCE THE REMOVAL OF THE DEVICE SYSTEM. SEE MFR REPORT # 3004209178-2008-04624.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8709| PROGRAMMER MODEL 8840