BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2893038 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-13304
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    July 27, 2012
    Report Date
    October 2, 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

    IT WAS REPORTED THE PATIENT HAD LOST WEIGHT AND THE IPG COULD BE SEEN, OR WAS PROMINENT UNDER THE SKIN. FOLLOW-UP IDENTIFIED THE PHYSICIAN REPOSITIONED THE IPG AND MADE THE POCKET SMALLER ON (B)(6) 2012. IT WAS REPORTED THE ISSUE WAS RESOLVED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3517932

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANT DATE: