BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2771974 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-12202
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 10, 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

    THE PATIENT REPORTED HAVING TRIAL LEADS REMOVED ON (B)(6) 2012. THE PATIENT REPORTED HE DEVELOPED AN INFECTION ON (B)(6) 2012. AN MRI WAS DONE AND SHOWED AN EPIDURAL ABSCESS AT THE T11-T12 LEVEL. THE PATIENT WAS PUT ON IV ANTIBIOTICS AND WAS DISCHARGED ON (B)(6) 2012. THE SJM REPRESENTATIVE MET WITH THE PHYSICIAN WHO REPORTED THE CULTURES WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3756844

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R