BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3092046 · Received May 3, 2013

    Report

    Report Number
    6000030-2013-00080
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 12, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J11173R18, IMPLANTED: 2002-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED CATHETER DISCONNECT AND WITHDRAWAL SYMPTOMS AFTER FALLING. PATIENT EXPLAINED THE FALL TOOK PLACE IN A GROCERY STORE WHEN SHE WAS GETTING IN A WHEELCHAIR AND THE ESTABLISHMENT¿S DOOR SHUT. PATIENT REPORTED SOMEONE GOT HER TO THE WHEELCHAIR AFTER THE FALL AND THEN ALL OF A SUDDEN SHE STARTED FEELING BAD AND THE CATHETER CAME LOOSE. SHE NOTED SHE HAD TO BE CUT OPEN TO RECONNECT THE CATHETER AND HAD BEEN INTO WITHDRAWAL TWICE. REPORTED SHE HAD PNEUMONIA. PATIENT ALSO NOTED SHE¿S CONSTANTLY FALLING. A FOLLOW UP HAVE BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAD BEEN PROVIDE AS OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PROVIDER STATED, ¿I DON¿T SEE ANY ISSUES WITH PUMP OR CATHETER SINCE HER TRANSFER TO OUR PRACTICE ON (B)(6).¿ THE PUMP WAS DELIVERING COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194787 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention