BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2212613 · Received August 11, 2011

    Report

    Report Number
    3004209178-2011-06279
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT WAS DIAGNOSED WITH A HEMATOMA OF THE INFERIOR ABDOMINAL WALL. A CT SCAN WITHOUT CONTRAST WAS DONE AND A HEMATOMA INFERIOR TO THE PUMP WAS OBSERVED. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO ADMINISTER DILAUDID AND BUPIVACAINE. SURGERY TO REMOVE THE HEMATOMA AND REVISE THE PUMP POCKET WAS PERFORMED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 H7814025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention