BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792178 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-03510
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 18, 2012
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT REPORTED THAT HE IS NO LONGER RECEIVING STIMULATION. THE SCS IPG IS NO LONGER COMMUNICATING WITH THE PATIENT PROGRAMMER OR CHARGING SYSTEM. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2881615

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3286 (3)