BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1052990 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02811
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0957-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED; THE HCP ASPIRATED THE SAME VOLUME PUT INTO THE PUMP AT THE LAST REFILL. THE PT HAD NO CHANGE IN HER BASELINE HYPERTONIA. THE PT'S TONE DID NOT IMPROVE AFTER SEVERAL RATE INCREASES. X-RAYS TAKEN IN 2008 AND ABOUT 2 MONTHS LATER WERE WITHIN NORMAL LIMITS. A CATHETER DYE STUDY COMPLETED IN 2008 SHOWED NORMAL FLOW. CATHETER ACCESS PORT ASPIRATIONS IN 2008 AND ABOUT 2 MONTHS LATER WERE NORMAL. A ROTOR STUDY COMPLETED IN 2008 APPEARED TO SHOW NO MOVEMENT OF THE ROTOR AFTER A PROGRAMMED BOLUS. THE STUDY WAS NOT OPTIMAL. THE HCP WAS WAITING FOR THE PT'S INFECTED SACRAL DECUBITUS ULCERS TO CLEAR BEFORE SCHEDULING SURGERY. THE HCP PLANNED TO RE-CHECK VOLUME DISCREPANCIES AND REPEAT THE ROTOR STUDY IN THE INTERIM. THE HCP REPORTED THE PT OUTCOME AS 'NO INJURY'. THE DEVICE SYSTEM WAS USED TO ADMINISTER LIORESAL. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT# L61553| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK