BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843498 · Received November 19, 2012

    Report

    Report Number
    1627487-2012-11698
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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 HAD LOST WEIGHT AND THE IPG POCKET SITE WAS PAINFUL. THE SJM REP MET WITH THE PT AND DETERMINED THE CHARGER WAS UNABLE TO LOCATE THE IPG. ON (B)(6) 2012 THE PHYSICIAN SECURED AND SUTURED THE IPG SO THAT IT WOULD LIE FLAT. F/U IDENTIFIED THE ISSUE WAS RESOLVED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3240783

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3288