BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3150946 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08758
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    August 17, 2012
    Report Date
    May 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BEGAN SOUNDING ITS CRITICAL ALARM ON THE DAY PRIOR TO REPORT. INTERROGATION SHOWED THAT A MOTOR STALL HAD OCCURRED ON (B)(6) 2012, ABOUT SIX MONTHS PRIOR TO IMPLANT. THE PUMP LOGS ALSO SHOWED THAT TUBE SET OCCURRED ON (B)(6), BEFORE THE STALL RECOVERED ON (B)(6). AT THE TIME OF REPORT, THE PATIENT WAS NOT FEELING GREAT AND WAS A LITTLE DIZZY. AT THE TIME OF REPORT, THE PUMP CONTAINED MORPHINE. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SOME PAIN, THOUGH IT WAS FROM A STEROID INJECTION THAT TOOK PLACE ON THE DAY PRIOR TO THE REPORTER MEETING THE PATIENT. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND WAS DOING FINE, PER THE PHYSICIAN. ABOUT TWO WEEKS AFTER THAT, IT WAS REPORTED THAT FIVE MOTOR STALLS OCCURRED BETWEEN (B)(6). ALL OF THE MOTOR STALLS RECOVERED, BUT TUBE SET OCCURRED THREE TIMES DUE OF THE MOTOR STALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251726 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR