BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2893036 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-13310
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 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 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

    REFERENCE MFR. REPORT: 1627487-2012-13309. THE PATIENT HAD TWO LEADS FROM THE SAME LOT NUMBERS. IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION. X-RAYS REVEALED THE PATIENT'S LEADS HAD MIGRATED. IT WAS ALSO REPORTED THE PATIENT HAD LOST APPROXIMATELY (B)(6) POUNDS SINCE THE SYSTEM WAS IMPLANTED AND THE DEVICES WERE SUPERFICIAL. FOLLOW-UP INFORMATION IDENTIFIED THE PHYSICIAN REPLACED THE ENTIRE SCS SYSTEM WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2785930

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention