BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2990489 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03354
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS THIS PATIENT HAD CARDIAC ARREST, WAS 'SERIOUSLY ILL' AND HOSPITALIZED IN THE INTENSIVE CARE UNIT. THE PHY SICIAN ELECTED TO TURN THE RATE DOWN TO THE MINIMUM RATE. THIS PATIENT WAS REPORTED TO BE HYPOTENSIVE. THIS DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93750 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R