BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4594722 · Received March 12, 2015

    Report

    Report Number
    3004209178-2015-04612
    Event Type
    Malfunction
    Date Received
    March 12, 2015
    Date of Event
    February 14, 2015
    Report Date
    February 16, 2015
    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: 8590-1, LOT# N242829, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONFIRMED MOTOR STALL AND RECOVERY WERE NOTED IN THE EVENT LOGS. IT WAS STATED THAT THE PATIENT HAD AN UNRELATED MRI (HIP) 2 DAYS PRIOR TO THE REPORT DATE. THE PATIENT WAS SEEN IN THE OFFICE ON THE DAY OF THE REPORT TO CHECK THE PUMP STATUS AFTER A 2 DAY HISTORY OF INCREASED PAIN. THE REPORTER DENIED WITHDRAWAL. THE EVENT LOGS SHOWED A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 14:34 AND THE STOPPED PUMP PERIOD MAY EXCEED TUBE SET OCCURRED ON (B)(6) 2015 AT 14:34; WITH A MOTOR STALL RECOVERY ON THE DAY OF THE REPORT AT 15:08. IT WAS STATED THAT THE PATIENT DID NOT HEAR AN AUDIBLE ALARM. THE MOTOR STALL WAS SEEN AS A FALSE MOTOR STALL. THE PHYSICIAN WAS TO EVALUATE THE INCREASED PAIN AND POSSIBLY PERFORM A CATHETER DYE STUDY. WHEN ASKED HOW THE PATIENT WAS DOING AND IF THEY WERE RECEIVING EFFECTIVE THERAPY, IT WAS STATED THAT EVERYTHING APPEARED NORMAL. THE PUMP WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170055 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR