BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3150032 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-15716
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES. 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

    THE PT REPORTED HE IS EXPERIENCING DISCOMFORT AT THE IPG SITE. THE PT STATED THE IPG SITE HAS BECOME INCREASINGLY SENSITIVE TO THE TOUCH AND IF HE SITS LONGER THAN 10-15 MINUTES, THE IPG FEELS LIKE IT IS POKING THROUGH HIS SKIN AND IS VERY UNCOMFORTABLE. THE PT IS VERY SLIM AND THE IPG APPEARS TO BE SHALLOW. THE PT IS TO MEET WITH HIS PHYSICIAN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237662 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2784777

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention SCS LEAD: MODEL: 3186| IMPLANT DATE: