BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1033614 · Received April 24, 2008

    Report

    Report Number
    6000030-2008-02172
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 24, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT UNDERWENT A SYSTEM REVISION WITH A DIAGNOSIS OF SEROMA. NO ANOMALIES WERE FOUND. THE FLUID WAS INITIALLY REPORTED AS CEREBROSPINAL FLUID. THE PHYSICIAN PLANNED TO REPLACE THE CATHETER; THIS PROCEDURE WAS NOT CONFIRMED. IT WAS LATER REPORTED BY THE HCP THAT THE EVENT WAS RELATED TO AN ABSCESS AND THE PT PRESENTED UNSPECIFIC INFECTION SYMPTOMS. THE PUMP AND CATHETER WERE EXPLANTED. NO PT OUTCOME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED:| CATHETER MODEL 8731SC LOT# N127730030| EXPLANTED: