BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1812210 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06141
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL OCCURRED FOLLOWING MRI (MAGNETIC RESONANCE IMAGING); MOTOR STALL RECOVERY NOT RECORDED IN THE EVENT LOGS APPROXIMATELY 40 MINUTES POST-MRI. THE PUMP WAS ALARMING. THE HCP TRIED TO UPDATE THE PUMP; THE STALL CONTINUED. THE HCP PLANNED TO RE-INTERROGATE THE PUMP. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703W, LOT# L47169