BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 819166 · Received February 15, 2007

    Report

    Report Number
    2182207-2007-00527
    Event Type
    Injury
    Date Received
    February 15, 2007
    Date of Event
    September 7, 2005
    Manufacturer
    METRONIC, INC., NEUROLOGICAL DIV
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STUDY. PATIENT DEVELOPED HEMATOMA AND FLUID COLLECTION IN THE PUMP POCKET, A SILVADENE DRESSING WAS APPLIED AND THE PATIENT WAS INSTRUCTED TO LEAVE THE DRESSING ON FOR 48 HOURS. OUTCOME: RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK LKK METRONIC, INC., NEUROLOGICAL DIV 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other CATHETER MODEL 8731, LOT# N003114408, IMPLANTED