BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012291 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-04310
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R,
    Adverse Event
    Yes
    Product Problem
    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 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: 1627487-2013-04311. IT WAS REPORTED THE PT WAS EXPERIENCING IPG POCKET HEATING WHILE USING THE CHARGING SYSTEM. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104515 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3423028

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANTED: