BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2230558 · Received August 12, 2011

    Report

    Report Number
    6000030-2011-06312
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 1, 2005
    Report Date
    August 2, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S "PUMP BROKE AND THE MEDICATION WENT TO THE WRONG AREA. PT SUFFERED FULL BLOWN WITHDRAWAL" THAT WAS RESOLVED.

    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 47 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J0056602R