BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2892334 · Received December 27, 2012

    Report

    Report Number
    1627487-2012-12853
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12854. IT WAS REPORTED THE PT IS EXPERIENCING POCKET HEATING NOT RELATED TO CHARGING. THE PT REPORTED TWO INCIDENTS OF HEATING, AND SAID THE SKIN FELT WARM TO THE TOUCH. IT WAS ALSO REPORTED THE STIMULATION IS TURNING ON AND OFF WITHOUT PROMPTING. X-RAYS SHOWED NO ANOMALIES. THE PHYSICIAN BELIEVES THE PT NEEDS A NEW IPG. NOTE THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3491150

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANTED: