BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012212 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-06048
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    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 A FIELD CORRECTION AND 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 FEELS A BURNING AND ACHING TO THE TOP AND RIGHT SIDE OF THE IPG AFTER HE'S BEEN MOVING AROUND AND SPECIALLY AFTER WEARING HIS CARE SEATBELT. THIS ISSUE WAS BEEN COMMUNICATED TO HIS PHYSICIAN, BUT HE HAS NOT MET WITH THE PHYSICIAN YET. THE NEXT COURSE OF ACTION HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104572 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3365377

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3163 (4)