BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3110682 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-05657
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 16, 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 INFORMATION 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

    ALLEGEDLY, THE PT'S IPG WAS NON-FUNCTIONAL. THE CHARGER AND PROGRAMMER COULD NO LONGER COMMUNICATE WITH THE IPG. DURING SURGICAL INTERVENTION, THE IPG WAS FOUND TO BE DISCONNECTED FROM THE LEADS. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION RESOLVED THE PT'S ISSUE. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208040 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 46155A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention