BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3102024 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-12625
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    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 2 OF 2. REFERENCE MFR REPORT #1627487-2013-12624. IT WAS REPORTED ONE OF THE PATIENT'S OCCIPITAL (OFF-LABEL USE) LEADS HAS MIGRATED. THE SJM REPRESENTATIVE REPROGRAMMED AND CAPTURED EFFECTIVE STIMULATION. THE PHYSICIAN PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE. NOTE: THE PATIENT RECEIVED TWO LEADS FROM DIFFERENT LOTS. BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197439 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3181 3187185

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788