BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201636 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11177
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ¿READY TO HAVE ANOTHER¿ MRI. IT WAS REPORTED THE REASON THE PATIENT WAS IN THE HOSPITAL WAS BECAUSE SHE HAD SURGERY BUT WAS NOT BECAUSE OF THE PUMP. IT WAS NOTED THE PUMP HAD BEEN FILLED A COUPLE OF DAYS AGO. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BACLOFEN. IT WAS LATER REPORTED A MOTOR STALL AND MOTOR STALL RECOVERY WERE RECORDED IN THE EVENT LOGS FOLLOWING AN MRI ON (B)(6) 2013. THE STALL WAS IN THE LOGS AT 15:57 WITH NO RECOVERY NOTED. THE REPORTER INTERROGATED A THIRD TIME ON (B)(6) 2013 AT 17:37 AND THE STALL RECOVERED. IT WAS NOTED THE PATIENT WAS ¿(B)(4)¿ AND HAD ¿SOME¿ SPASMS. IT WAS NOTED IT WAS ¿NORMAL¿ FOR THE PATIENT TO HAVE ¿SOME¿ SPASMS. IT WAS NOTED THE PATIENT ALSO HAD AN MRI ON (B)(6) 2013 AND A MOTOR STALL AND RECOVERY OCCURRED AS A RESULT OF THAT EVENT HOWEVER THE LENGTH OF THE STALL WAS NOT PROVIDED. IT WAS NOTED IT WAS ¿UNCLEAR¿ IF THE PATIENT HAD ANY ALARMS. THE REPORTER DID NOT HEAR ANY. IT WAS LATER CONFIRMED THE STALL DID NOT RECOVER WITHIN TWO HOURS. THE PATIENT WAS REPORTEDLY RECEIVING EFFECTIVE THERAPY AND ¿NO OTHER CALLS¿ WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303405 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR