BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2961863 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02648
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 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
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2012, THE PATIENT SAW THE SURGEON AND A DOSE CHANGE WAS MADE. THE MANAGING PHYSICIAN WAS NOT MADE AWARE OF THE DOSING CHANGE AND THE PATIENT'S PUMP WAS NOW EMPTY. THE EMPTY RESERVOIR ALARM OCCURRED AND WAS SEEN ON INTERROGATION. THE PUMP LOGS SHOWED THE EMPTY RESERVOIR LOG ON (B)(6) 2013. THE PATIENT WAS AT THE CLINIC ON (B)(6) 2013 AND THEY WERE PLANNING TO REFILL THE PUMP; THEY WERE PLANNING TO CHANGE THE LIORESAL CONCENTRATION FROM 500 MCG/ML TO 2000 MCG/ML. THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS RELATED TO THE EVENT; THE PATIENT'S LEGS WERE TIGHT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT EXPERIENCED INCREASED SPASTICITY. THE PATIENT OUTCOME WAS NO INJURY. THE PATIENT HEARD THE ALARM, BUT IGNORED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65159 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1