BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1181189 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06214
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH "DECUBITUS" AT THE PUMP POCKET. THE PUMP WAS REPLACED. THE PATIENT WAS DOING WELL AFTER THE REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PUMP WAS USED TO DELIVER BACLOFEN.

    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