BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3010665 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-03372
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03373. THE PT REC'D 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS EXPERIENCING NEW PAIN AROUND HER SCS IPG POCKET SITE. IT WAS ALSO REPORTED THE PT IS NO LONGER RECEIVING EFFECTIVE STIMULATION. THE PT REPORTEDLY ATTRIBUTES THE NEW PAIN TO HER SCS SYSTEM AND SUBSEQUENTLY REQUESTED THE EXPLANT OF HER SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108319 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 64688

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention