BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973346 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13816
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A "PROCEDURE", THE PATIENT HAD OVERDOSE SYMPTOMS; FELT DIZZY AND LIGHT HEADED. THE PATIENT WAS BROUGHT BACK INTO THE EXAM ROOM TO MONITOR. THE PATIENT RECOVERED QUICKLY AND WAS SENT TO A LOCAL ER (EMERGENCY ROOM). THE PATIENT WAS CLEARED AND DISCHARGED A FEW HOURS LATER. A HOSPITALIZATION WAS NOTED. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450712 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization