BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3111307 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07613
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL #(B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HEARD A NON-CRITICAL ALARM FROM THE PUMP THREE TIMES IN THE BEGINNING OF (B)(6) 2013. THE REPORTER STATED THAT THE PUMP WOULD NEED TO BE REPLACED DURING THE UPCOMING SUMMER DUE TO THE BATTERY. IT WAS NOTED THAT THE PUMP HAD JUST BEEN REFILLED IN (B)(6) 2013. THERE WAS NO CHANGE IN THE PATIENT'S THERAPY, HOWEVER, IT WAS NOTED THAT THE PATIENT WOULD FEEL BURNING IN HER LEGS WHENEVER IT WOULD RAIN OR SNOW. THE PATIENT EXPERIENCED INCREASED SPASTICITY AND PAIN. THE PUMP WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. A DYE STUDY WAS PERFORMED ON (B)(6) 2013 AND RESULTS WERE THE CATHETER WAS IN THE INTRATHECAL SPACE. A ROLLER STUDY WAS PERFORMED ON (B)(6) 2013 AND NO PROBLEMS WERE NOTED. THE PATIENT WAS IN THE HOSPITAL FOR PAIN CONTROL, AND THEN DEVELOPED PNEUMONIA. THE PATIENT HAD A HISTORY OF PNEUMONIA. THE PATIENT HAD SWALLOWING DIFFICULTIES, AND WAS BEING WORKED UP FOR ASPIRATION PROBLEMS. THE PATIENT WAS STILL IN THE HOSPITAL RECOVERING ON THE DATE OF THIS REPORT. THE PUMP WAS DELIVERING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212112 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization