BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872214 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07963
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. ALARM WAS NOT HEARD. PUMP WAS IN SAFE STATE. THE PT STATED THAT THEY HAD NO MAGNETIC RESONANCE IMAGING (MRI) OR ANYTHING OUT OF THE ORDINARY. PT WAS IN THE CAR AT THAT TIME TRYING TO USE HER PT MONITOR (PTM). PTM SHOWED ERROR CODE OF 8478 THAT SHOWED PUMP WAS IN SAFE STATE AND PUMP WAS ALARMING. IT WAS LATER REPORTED ALARM WAS HEARD AND TELEMETRY WAS NOT YET PERFORMED. TROUBLESHOOTING WAS LIMITED DUE TO LACK OF ACCESS TO PRODUCT AND/OR PT. THE PUMP CONTAINED MORPHINE WITH A CONCENTRATION OF 10 MG/ML AND MARCAINE WITH A CONCENTRATION OF 3.7 MG/ML. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N209264023| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG013319N