BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1800022 · Received August 12, 2010

    Report

    Report Number
    3004209178-2010-06074
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 14, 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 A CONFIRMED MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. IT WAS STATED MOTOR STALL CAUSED BY PT HAVING MRI OR OTHER MEDICAL PROCEDURE. THE PT HAD AN MRI ABOUT 4+ HOURS EARLIER AND THE PUMP STILL SHOWED A STALL AND STILL ALARMED. THE LOGS WERE CHECKED AND IT WAS NOTED THAT THERE WERE NO OTHER MOTOR STALLS EXCEPT ONE AROUND THE TIME THAT THE PT REPORTED HAVING AN MRI. ADDITIONAL INFO WILL BE PROVIDED WHEN 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 62 YR CATHETER: MODEL 8709, LOT# J11643R17| EXPLANTED:| IMPLANTED: