BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1040517 · Received May 9, 2008

    Report

    Report Number
    2182207-2008-02510
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    November 1, 2006
    Report Date
    April 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION IN THE PUMP POCKET RELATED TO PUMP ACCESS. THE PT HAD 5 DAYS OF DISCHARGE FROM THE PUMP POCKET WHICH WAS INITIALLY SEROUS, BUT LATER BECAME PURULENT. THE PUMP AND CATHETER WERE EXPLANTED, THE INFECTION WAS TREATED, AND THE SYSTEM WAS REPLACED. THE PT WAS REPORTED TO HAVE RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO ADMINISTER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| CATHETER MODEL 8709 LOT# N062083024