BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1150453 · Received September 5, 2008

    Report

    Report Number
    3004209178-2008-05508
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED A HEMATOMA FOLLOWING PUMP REPLACEMENT. A POOL OF BLOOD WAS NOTED IN THE BED. THE PT WAS TAKEN TO SURGERY FOR REVISION; THE PT WAS DOING WELL AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637 NA

    Patients

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