BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2993973 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10070
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 COMMUNICATION COULD NOT LONGER BE ESTABLISHED BETWEEN THE SCS IPG AND EXTERNAL DEVICES (CHARGING SYSTEM AND PT PROGRAMMER). IT WAS NOTED THE LAST TIME THE PT HAD SUCCESSFULLY CHARGED THE IPG WAS IN (B)(6) 2012. THE PT HAS SINCE LOST STIMULATION ((B)(6)). ADD'L CHARGING SYSTEMS AND PT PROGRAMMERS WERE TRIED TO NO AVAIL. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89281 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3428597

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention