BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3912762 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12501
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709, LOT# L74638, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXTREMELY LETHARGIC AND THEY WANTED THE PUMP TURNED OFF. THEY DID NOT HAVE ACCESS TO A PROGRAMMER, SO THEY NEEDED A MANUFACTURER REPRESENTATIVE PAGED. THE PUMP WAS ADJUSTED ON TUESDAY, AND THE PATIENT¿S SYMPTOMS STARTED ON THE DATE OF THE REPORT. THE REPORTER STATED THE PATIENT WAS COMPLETELY OUT OF IT. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT. IT WAS NOTED THE PATIENT HAD A LOT GOING ON AND THEY SUSPECTED THE PATIENT WAS SEPTIC AND HAD AN INFECTION. THE PUMP SYSTEM WAS BEING USED TO DELIVER DILAUDID. 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
    389712 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00095 YR Hospitalization