BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4212848 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-06306
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 4, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS NOT RECEIVING STIMULATION ON THE RIGHT SIDE. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED THE RIGHT LEAD (CONTACTS 9-16) WERE ALL INVALID. THE PATIENT IS WORKING WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678623 OCTRODE GZB ST. JUDE MEDICAL NEUROMODULATION SYSTEMS 3186 4246488

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788,| SCS ANCHOR, MODEL 1192,