BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2081060 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02833
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS "SICK" AND HAD BEEN THROWING UP SINCE (B)(6) 2011. THE PUMP WAS REFILLED ON (B)(6) 2011. THE PUMP CONTAINED MORPHINE. AT THAT TIME, THE PUMP WAS INTERROGATED AND REVEALED IT HAD NOT BEEN WORKING FOR 48 HOURS. THE PUMP WAS RESTARTED AND THE PT WAS GIVEN ORAL MORPHINE TO HELP CONTROL PAIN SYMPTOMS. AS OF THE DATE OF THIS REPORT, THE PUMP BEGAN ALARMING AGAIN; THE PT HEARD A SINGLE TONE BEEP. THE PT HAD AN APPOINTMENT TO SEE THE HCP LATER THAT DAY. PUMP REPLACEMENT WAS BEING CONSIDERED. ADDITIONAL INFO 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
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CATHETER: MODEL 8709, LOT # N061490008| IMPLANTED:| EXPLANTED: