BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2934465 · Received January 28, 2013

    Report

    Report Number
    1627487-2013-04100
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    September 6, 2012
    Report Date
    January 8, 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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    REFERENCE MFR REPORT: 1627487-2013-04101. THE PATIENT RECEIVED TWO LEADS THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT HAD AN INCREASED RECHARGE BURDEN, AND USED THE SCS SYSTEM CONTINUOUSLY. FOLLOW UP IDENTIFIED THE PATIENT HAD REQUESTED FOR THE SCS SYSTEM TO BE REMOVED DUE TO UNSATISFACTORY PAIN RELIEF. THE PHYSICIAN EXPLANTED THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37361 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3202969

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)