BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4180027 · Received October 15, 2014

    Report

    Report Number
    1627487-2014-01655
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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 PATIENT LOST THE CHARGER DURING A DOMESTIC DISPUTE. AS A RESULT, SHE HAS BEEN UNABLE TO RECHARGE THE IPG IN SEVERAL MONTHS. TROUBLESHOOTING WITH ALTERNATE EXTERNAL DEVICES WAS ATTEMPTED BY THE SJM REPRESENTATIVE TO NO AVAIL. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING AND REPLACING THE IPG. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655378 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3782292

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192(2)| SCS LEAD: MODEL 3183(2)