BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052308 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-01397
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 15, 2013
    Report Date
    February 22, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT IS NOT RECEIVING STIMULATION AND IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. A SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139705 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3185659

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL: 1192 (2)| SCS LEAD: MODEL: 3186 (2)| SCS ANCHOR: MODEL: 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL: 3186 (2)