BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2930330 · Received January 21, 2013

    Report

    Report Number
    1627487-2013-04079
    Event Type
    Injury
    Date Received
    January 21, 2013
    Date of Event
    August 22, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. 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 THE PATIENT HAD AN INCREASED RECHARGE BURDEN. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. FOLLOW UP IDENTIFIED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION AT A FUTURE DATE TO REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28832 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2831144

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD, MODEL 3214| SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE: