BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2384396 · Received December 21, 2011

    Report

    Report Number
    3004209178-2011-09969
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    August 12, 2011
    Report Date
    November 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, LOT #: J11300R39, IMPLANTED: (B)(6)-2002, EXPLANTED: UNK; CATHETER POUCH MODEL: 8590-1, LOT #: N133648, IMPLANTED: (B)(6)-2008, EXPLANTED: UNK.

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY WAS REPORTED. IT WAS ADDED THAT THERE WERE SEVERAL MOTOR STALLS AND RECOVERIES IN LOGS WITH NO FINAL RECOVERY. IT WAS NOTED THAT THE PUMP RESTARTED EVERY TWO DAYS SINCE (B)(6) 2011 AND ALSO HAD BATTERY RESET AND SAFE STATE MESSAGES; STALLED LONGER AND MAY DAMAGE CATH, LOW BATTERY. PATIENT DID NOT HAVE A RETURN OF SYMPTOMS; HOWEVER WAS HOSPITALIZED FOR "UNRELATED ISSUES" PER REPORTER. DRUG DELIVERED VIA THE PUMP WAS MORPHINE 25MG/ML AT A DAILY DOSE OF 4MG. IT WAS LATER ADDED THAT A PUMP CHANGE WAS BEING PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00095 YR