BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1083472 · Received July 29, 2008

    Report

    Report Number
    3004209178-2008-04469
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MAY HAVE MENINGITIS, WHICH WAS INITIALLY BELIEVED TO BE AN INFECTION AT THE PUMP POCKET. SYSTEM REMOVAL WAS PLANNED. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 Required Intervention CATHETER MODEL #: 8703W| LOT #: L46690| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED:| IMPLANTED: