BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3092681 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01529
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703W, LOT# L70179, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REFILL APPOINTMENT, UPON OBTAINING TELEMETRY OF THE PUMP, A MOTOR STALL WAS NOTED WITH A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE. THE PUMP LOGS WERE THEREFORE REVIEWED AND THERE WERE TWO MOTOR STALLS WITH RECOVERY ON (B)(6) 2013. THE PATIENT NOTED HAVING A MAGNETIC RESONANCE IMAGING (MRI) STUDY ON (B)(6) 2013. THERE WAS ANOTHER MOTOR STALL RECORDED ON (B)(6) 2013, FOLLOWED BY ONE "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE, WHICH WAS REPORTED TO BE ON (B)(6) 2013. THE REPORTER LATER INDICATED THAT WHEN THE LATEST PUMP LOGS WERE READ, THE LAST INDICATION WAS "MOTOR STALL RECOVERY OCCURRED." AFTER REVIEW OF ALL REPORTED INFORMATION, THE EVENT SUGGESTED A POSSIBLE FALSE MOTOR STALL, BUT THIS WAS NOT CONFIRMED; ALTHOUGH IT DID APPEAR THAT THE LAST MESSAGE WITHIN THE LOGS WAS A RECOVERY. IN ADDITION, IT WAS NOTED THAT IT WAS POSSIBLE THAT THE PATIENT HAD ANOTHER MRI WHICH CAUSED THE SECOND MOTOR STALL EVENT. THE PUMP WAS BEING USED TO DELIVER SUFENTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193658 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR