BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950524 · Received July 10, 2014

    Report

    Report Number
    1627487-2014-25502
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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#: 1627487-2014-25503. THE PATIENT HAS TWO SCS LEADS WITH THE SAME LOT NUMBER AND THREE SCS ANCHORS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS EXPERIENCING INEFFECTIVE COVERAGE AND STIMULATION IN UNINTENDED AREAS DUE TO THE LEADS AND ANCHORS MIGRATING, CONFIRMED WITH X-RAYS. REPROGRAMMING ATTEMPTS DID NOT PROVIDE RESOLUTION. IN TURN, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403868 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4424815

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3789