BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 3161432 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-06403
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 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 3 OF 8. REFERENCE MFR REPORT: 1627487-2013-06401, 06402, 06404, 06405, 06406, 06407, 06408. THE PATIENT WAS IMPLANTED WITH TWO SYSTEMS. THE PATIENT HAS EIGHT LEADS (FROM FIVE SEPARATE LOTS) AND FOUR EXTENSIONS (FROM THREE SEPARATE LOTS) FOR OCCIPITAL AND SUPRA-ORBITAL STIMULATION (OFF-LABEL). IT IS UNKNOWN WHICH DEVICES WERE REMOVED, THEREFORE, ALL POSSIBLE DEVICES ARE BEING REPORTED. IT WAS REPORTED THE PATIENT LOST STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT SURGICAL INTERVENTION AND TWO OF THE LEADS AND ONE EXTENSION WERE REPLACED. THE PATIENT REPORTED EFFECTIVE STIMULATION POST-OPERATIVE. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249327 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3346 3218973

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716| SCS IPG: MODEL 3716