BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3022403 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-01339
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C 1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-05242011-002-R, 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-1340. IT WAS REPORTED THE PT IS EXPERIENCING POCKET HEATING AT HER IPG SITE WHILE CHARGING. A NEW LE CHARGER WAS SENT TO THE PT TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119536 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2865303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD: MODEL 3219| IMPLANT: