BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 2934288 · Received January 7, 2013

    Report

    Report Number
    1627487-2013-13009
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 ADVISORY. 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 WAS EXPERIENCING SOME PAIN AT HER IPG POCKET SITE. THE PT STATED THE PAIN OCCURRED WHEN SHE BENT DOWN OR GOT UP FROM A SITTING POSITION. IT WAS ALSO NOTED THE PT HAD GAINED SOME WEIGHT SINCE THE IMPLANT OF HER SCS SYSTEM. THE PT WAS TO FOLLOW-UP WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8495 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2857934

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3341| SCS LEAD: MODEL 3186 (3)