BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3203575 · Received July 3, 2013

    Report

    Report Number
    2182208-2013-00462
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    July 9, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), EXPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S PUMP RESERVOIR WENT EMPTY AND THE PATIENT EXPERIENCED ¿A LOT OF PAIN¿. THE PUMP WAS REPLACED BY THE HCP. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304989 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention