BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141619 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-12719
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. THIS MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT USED THE MAGNET TO TURN OFF THE SCS SYSTEM AND WAS 'ZAPPED' BY THE SYSTEM. AT THAT TIME SHE WAS ABLE TO TURN THE STIMULATION ON. ON (B)(6) 2013, THE PT ATTEMPTED TO CHARGE THE SYSTEM AND THE IPG WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE EXTERNAL DEVICES. THE PT PLANS TO UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232509 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3121737

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANTED: