BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2881314 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-06951
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2012-06952. IT WAS REPORTED THE PATIENT HAS BEEN IN SEVERAL MOTOR VEHICLE ACCIDENTS. IT WAS ALSO REPORTED THE PATIENT HAS NOT RECEIVED ADEQUATE PAIN RELIEF. THE PATIENT'S IPG WAS EXPLANTED DUE TO PAIN AT THE IPG SITE. THE PAIN REMAINS AT THE SITE, BUT IS BETTER THAN PRIOR. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 86251

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention