BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141706 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-04646
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 4, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS UNABLE TO RECHARGE THE IPG, AND A REPLACEMENT CHARGING SYSTEM DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THE IPG MAY BE TILTED, WHICH COULD BE CAUSING DIFFICULTY COMMUNICATING BETWEEN THE CHARGING SYSTEM AND THE IPG. IT WAS REPORTED THE PHYSICIAN MAY UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230652 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3845084

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3186 (2)| IMPLANTED:| SCS ANCHOR: MODEL 1192 (2)