BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4092017 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-21568
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 REC'D TWO SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO IMPLANT A NEW LEAD TO IMPROVE STIMULATION COVERAGE. IT WAS REPORTED THE PHYSICIAN CONNECTED THE EXISTING OCTRODE LEADS TO A DUAL EXTENSION. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518766 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3186 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS IPG, MODEL 3788| IMPLANT DATE: