BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4001569 · Received June 30, 2014

    Report

    Report Number
    1627487-2014-12439
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THE PATIENT'S IPG POCKET SITE WAS RELOCATED TO MOVE IT OUT OF THE WAY OF ANOTHER PROCEDURE THE PATIENT WAS HAVING. DURING THE RELOCATION, THE PHYSICIAN ELECTED TO REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380400 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 2832500

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS EXTENSION: MODEL 3341 (2)| SCS LEAD: MODEL 3169 (4)| IMPLANT DATE:| IMPLANT DATE: