BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3073161 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06775
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 27, 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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP BEGAN ALARMING THE EVENING PRIOR TO THE REPORT. THE PATIENT PRESENTED TO THE HOSPITAL ON THE DAY OF THE REPORT AND THE NURSE INTERROGATED THE PUMP AND DID NOT SEE AN ACTIVE ALARM IN THE PUMP LOGS. AT THIS TIME THE PATIENT HAD NOT SIGNS OF UNDERDOSE OR OVERDOSE. THE PUMP WAS REFILLED AND THE ACTUAL VOLUME WAS AS EXPECTED AT 6.3ML. THE PATIENT WAS SENT HOME. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED "A FEW WEEKS AGO" PRIOR TO THE REPORT. THE PATIENT HAD DEVELOPED A RESPIRATORY INFECTION FOLLOWING A SAUNA OF 60 DEGREES CELSIUS. AT THIS TIME, THE PATIENT WAS VERY SPASTIC, SWEATING, WITH FEVER AND SHOWING UNDERDOSE SYMPTOMS. AT THE TIME OF THE REPORT, THE PATIENT WAS NOT SPASTIC AND THE PATIENT OUTCOME WAS REPORTED AS "GOOD". THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175525 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization