BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960549 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-12485
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 1 OF 2. REFERENCE MFR REPORT NUMBER 1627487-2014-12486. IT WAS REPORTED THE PHYSICIAN PLACED TWO LEADS FOR A PERMANENT PROCEDURE. STIMULATION WAS TESTED IN THE OPERATING ROOM. THE PATIENT REPORTED SHE WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PHYSICIAN REMOVED THE LEADS AND ABANDONED THE CASE. THE PATIENT WILL BE REFERRED FOR A PADDLE LEAD PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426578 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4128138

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other