BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 7143441 · Received December 22, 2017

    Report

    Report Number
    1627487-2017-08533
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 22, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2: REFERENCE MANUFACTURER REPORT: 1627487-2017-08536. IT WAS REPORTED THE PATIENT WAS NOT GETTING RELIEF AND THE LEADS WERE UNCOMFORTABLE. A COMPANY REPRESENTATIVE OFFERED TO MEET WITH THE PATIENT TO TRY TO ADJUST THE STIMULATION, THE PATIENT DECLINED. SURGICAL INTERVENTION WAS TAKEN TO EXPLANT THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922971 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 5519284

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other MODEL 1192 SCS ANCHORS (X 2)| MODEL 3771 SCS IPG