BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3223198 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-06588
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    September 4, 2012
    Report Date
    June 14, 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
    TN, 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 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 HAS NOT USED OR CHARGED HER SCS IPG IN TWO YEARS DUE TO HER PAIN IMPROVING. THE PATIENT MET WITH HER PHYSICIAN AFTER ATTEMPTING TO USE HER SYSTEM AND IT WAS CONFIRMED HER IPG WAS INOPERABLE. FOLLOW-UP IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION AND HER IPG WAS REPLACED WITH A NON-RECHARGEABLE ONE. THE ISSUE HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314646 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3158083

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: