BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2980032 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-01207
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-01208. THE PATIENT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT'S IPG WAS SUPERFICIAL DUE TO WEIGHT LOSS. IT WAS ALSO REPORTED IT WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PATIENT UNDERWENT REVISION SURGERY WHERE HER IPG WAS REPLACED WITH A SMALLER ONE AND HER LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77958 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3491150

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SCS EXTENSION: MODEL 3346 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3049 (2)| IMPLANT DATE: