BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980066 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-04233
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    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 CORRECTION. SJM HAS LIMITED INFO 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. REF MFR REPORT: 1627487-2013-04234. IT WAS REPORTED THE PT HAD EXPERIENCED WARMTH AT THE IPG SITE WHILE CHARGING. IN ADDITION, THE PT HAD EXPERIENCED SHOCKING SENSATIONS AT THE IPG POCKET SITE WITH POSITIONAL CHANGES; THE SHOCKING OCCURRED WHILE THE SCS SYSTEM WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77963 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3762184

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)