BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122111 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07969
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 24, 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

    PRODUCT ID: 8709, LOT# L78689, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED AND REPLACED. INITIALLY, THE PUMP ALARM WAS HEARD AND THE PATIENT EXPERIENCED A LITTLE BIT OF ¿INCONSISTENCE¿. IT WAS FOUND THAT THE PUMP HAD BEEN IN SAFE STATE, A RESET OCCURRED, A MOTOR STALL OCCURRED, AND IN WAS NOTED THAT THE STOPPED PUMP PERIOD MAY EXCEED TUBE SET. THE PHYSICIAN HAD SEEN THESE A COUPLE DAYS PRIOR TO REPORT. IT WAS NOTED THAT THE PUMP WENT INTO RESET MODE AT 60 MONTHS. THE LOGS SHOWED THAT THE PUMP WAS LAST CHANGED ON (B)(6). THE DEVICE WAS DELIVERING LIORESAL. TWO WEEKS LATER, IT WAS REPORTED THAT THE CAUSE OF THE MOTOR STALL WAS UNKNOWN. IT WAS ALSO NOTED THAT THE REPORTER WAS UNABLE TO ACCESS THE PUMP LOGS OR INTERACT WITH THE PUMP. THE REPORTER DIDN¿T KNOW HOW THE PATIENT WAS DOING AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224674 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention