BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2926079 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-13091
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 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

    THE PT HAD TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAD LOST STIMULATION COVERAGE OF HER LOWER BACK AREA. X-RAYS IDENTIFIED THE PT'S TRIAL LEADS HAD MIGRATED. THE PT'S LEADS WERE EXPLANTED DUE TO AN INFECTION AT THE LEAD SITE. THE PT WAS TREATED WITH ORAL ANTIBIOTICS. F/U PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26492 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3086 3831995

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention