BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3231525 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-04890
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 20, 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
    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 INFO 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 HAD NOT RECHARGED THE IPG FOR OVER A YEAR. THE SJM REP MET WITH THE PT AND CONFIRMED THE IPG WOULD NOT COMMUNICATE WITH THE EXTERNAL DEVICE. F/U IDENTIFIED THE PHYSICIAN WAS TO UNDERTAKE SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324739 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3148358

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192