BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3203020 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00076
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 18, 2012
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, SERIAL# UNKNOWN, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCP HAD DIFFICULTY INTERROGATING THE IMPLANTABLE PUMP. THE HCP WAS ABLE TO INITIALLY INTERROGATE AND UPDATE THE PUMP, BUT A SUBSEQUENT ATTEMPT TO INTERROGATE THE PUMP TO MAKE ADDITIONAL CHANGES WAS UNSUCCESSFUL. INTERROGATION WAS ATTEMPTED IN A DIFFERENT ROOM AS WAS SUCCESSFUL. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303061 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR