BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP

    MDR report key: 3170583 · Received April 12, 2013

    Report

    Report Number
    3170583
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A SYNCHROMED INTRATHECAL PAIN PUMP IMPLANT SURGICALLY REMOVED DUE TO PUMP RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159831 MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP INTRATHECAL PAIN PUMP LKK MEDTRONIC 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O