BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200989 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11163
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET INFECTION. THE PUMP AND CATHETER WERE EXPLANTED. THE PATIENT REQUIRED HOSPITALIZATION. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THAT AS OF (B)(6) 2013 THE PATIENT WAS STILL IN THE HOSPITAL. THE INFECTION ¿SEEMS TO BE RESOLVED¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301680 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R