BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110820 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-05645
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT NUMBER: 1627487-2013-05646. IT WAS REPORTED THE PT EXPERIENCES DISCOMFORT AND PAIN AT THE IPG SITE A DAY AFTER RECHARGING. THE PT WILL BE ISSUED A REPLACEMENT CHARGER TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204819 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3797074

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT: