BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4180039 · Received October 15, 2014

    Report

    Report Number
    1627487-2014-01653
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 21, 2014
    Report Date
    February 16, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    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.

    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 EXPERIENCED A RECENT FALL. AS A RESULT, THE IPG IS UNABLE TO COMMUNICATE WITH ANY EXTERNAL DEVICES. FURTHERMORE, THE PATIENT PROGRAMMER DISPLAYS AN ERROR MESSAGE. X-RAYS WILL BE TAKEN AS THE NEXT COURSE OF ACTION.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652875 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 4425199

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SCS LEAD: MODEL 3288| IMPLANT DATE: