BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2861320 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-06855
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 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 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 2 OF 3. REFERENCE MFR REPORT NUMBER: 1627487-2012-06853 AND 06854. IT WAS REPORTED, THE PT WAS NOT RECEIVING ADEQUATE COVERAGE. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. IT WAS ALSO REPORTED, THE PT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, THE PT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, ONE OF THE PT¿S LEADS WAS FOUND TO HAVE MIGRATED. AS A RESULT, THE PT¿S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3716 3597339

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention