BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3810572 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-26383
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PT'S IPG IS UNABLE TO COMMUNICATE WITH HIS CHARGER HENCE; THE PT HAS BEEN UNABLE TO RECHARGE HIS IPG AND AS A RESULT, HE IS NOT RECEIVING STIMULATION. IN THE PAST THE PT HAS ALLOWED HIS IPG TO FULLY DISCHARGE BUT HE WAS ABLE TO RECHARGE HIS IPG AFTERWARDS. FOLLOW UP INFO IDENTIFIED COMMUNICATION WAS UNABLE TO BE ESTABLISHED BETWEEN THE IPG NAD EXTERNAL DEVICES (CHARGING SYSTEM AND PT PROGRAMMER. THE PT REPORTS HE UNDERWENT HIP REPLACEMENT SURGERY (B)(6) 2013 AND HAS NOT USED HIS SCS SYSTEM SINCE THEN. THE PT COULD NOT RECALL THE LAST TIME HE RECHARGED HIS IPG. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271708 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2893854

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3146