BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3141614 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-15690
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 20, 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 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

    IT WAS REPORTED THE PT'S RECHARGE BURDEN HAD INCREASED. THE PT'S IPG WAS EXPLANTED AND REPLACED. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231851 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 48973

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS EXTENSION: MODEL 3343 (2)| IMPLANTED:| SCS LEAD: MODEL 3156 (2)| IMPLANTED:| SCS LEAD: MODEL 3146 (2)| IMPLANTED: