BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 4163498 · Received October 10, 2014

    Report

    Report Number
    3007566237-2014-02923
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 17, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT THROUGH WITHDRAWAL WHEN HE FIRST GOT THE PUMP. THE REASON WAS THAT HE HAD MOVED FROM OR TO MT AND HADN¿T LINED ANYONE UP TO FILL THE PUMP. HIS WITHDRAWAL SYMPTOMS HAD CONSISTED OF A METALLIC TASTE, SMELLING A CERTAIN ODOR, CRAMPS AND HE FELT LIKE HE WAS GOING TO DIE. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE EVENT WAS NOT PROVIDED. FURTHER INFORMATION INCLUDING THE PATIENT¿S OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639094 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1