BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2190913 · Received July 19, 2011

    Report

    Report Number
    1627487-2011-00994
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00995. THE PT'S SCS SYS INCLUDES AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT THE PT IS EXPERIENCING PRESSURE BETWEEN HER SHOULDERS. THE DISCOMFORT HAS ALLEGEDLY BEEN PRESENT SINCE HER LEAD REPLACEMENT PROCEDURE LAST YEAR, (REFERENCE MFR REPORT # 1627487-2010-00314) BUT HAS RECENTLY BECOME MORE OF AN ISSUE. NUMEROUS REPROGRAMMING ATTEMPTS HAVE BEEN UNDERTAKEN TO RESOLVE THE REPORTED PRESSURE, AND IT IS SAID TO DISSIPATE ONCE A CERTAIN AMPLITUDE LEVEL IS REACHED. ADDITIONALLY, THE PT ALLEGES EXPERIENCING INTERMITTENT STIMULATION WHICH IS POSITIONAL IN NATURE AS WELL AS AN INCREASED RECHARGE BURDEN FOR HER IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3103961

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS LEAD ANCHOR: MODEL 1192| IMPLANTED: