BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2800905 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-06582
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 24, 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 HAS TWO LEADS (FROM THE SAME LOT) FROM OFF-LABEL USE. IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THE LEAD SITE. THE PATIENT IS ALSO EXPERIENCING SWELLING AND DRAINAGE. THE INFECTION IS BEING TREATED WITH ORAL ANTIBIOTICS. ALLEGEDLY, THE PHYSICIAN DOES NOT THINK THE INFECTION IS RELATED TO THE SCS SYSTEM. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION ON A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3744686

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788| IMPLANT:| SCS EXTENSIONS: MODEL: 3383(2)