BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3001498 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-02325
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE PT WAS UNABLE TO CHARGE HER IPG AND SHE COMPLAINED OF A BURNING SENSATION AT THE IPG SITE. F/U IDENTIFIED THE PHYSICIAN EXPLANTED AND REPLACED THE IPG WITH A SMALLER MODEL ON (B)(6) 2013. IT WAS REPORTED THE ISSUES WERE RESOLVED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93651 EON SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3716 48502

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: