BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2081059 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02837
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 1, 2011
    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

    A PUMP ALARM WAS OCCURRING DUE TO ZERO ML RESERVOIR VOLUME REACHED AND MOTOR STALL. THE PT WAS GIVEN ORAL PAIN MEDICATION. THE PUMP CONTAINED MORPHINE 10MG/ML. THERE WERE CONFIRMED MOTOR STALLS AND RECOVERIES NOTED IN THE EVENT LOGS. TWO MOTOR STALLS OCCURRED (WITH RECOVERIES THE SAME DAY) ON (B)(6) 2010 AND (B)(6) 2011. THE MOTOR STALL ON (B)(6) 2011 OCCURRED FOR ABOUT ONE HOUR, THE PT DID NOT HAVE MAGNETIC RESONANCE IMAGING ON THAT DATE. THE PT HAD MAGNETIC RESONANCE IMAGING IN THE PAST BUT COULD NOT REMEMBER WHEN DUE TO MEMORY LOSS ISSUES. THE EXPECTED RESIDUAL VOLUME WAS APPROXIMATELY 2 ML; THE ACTUAL RESIDUAL VOLUME WAS APPROXIMATELY 18 ML. THE PUMP WAS LOOSE IN THE POCKET. SURGERY WAS PLANNED TO OCCUR (B)(6) 2011 TO REVISE THE PUMP AND CHECK IF THE CATHETER WAS TWISTED DUE TO THE PUMP FLIPPING BACK AND FORTH IN THE POCKET. 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 8637-201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CATHETER: MODEL 8709SC, LOT # N22914009| EXPLANTED:| IMPLANTED: