BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2191006 · Received July 19, 2011

    Report

    Report Number
    6000030-2011-05558
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    RICK CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM ACCESSING THE CATHETER ACCESS PORT. THE HEALTH CARE PROVIDER WAS ALSO UNABLE TO FILL OR ASPIRATE THE RESERVOIR. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFO HAS BEEN REQUESTED; F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICK CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR EXPLANTED:| CATHETER: MODEL 8575, LOT# J0187431R| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11011R33| IMPLANTED:| IMPLANTED: