BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2864399 · Received December 6, 2012

    Report

    Report Number
    1627487-2012-13168
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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

    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 HAD TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. HE STATED IN ORDER TO FEEL ANY STIMULATION, HE WOULD HAVE TO TURN THE AMPLITUDE UP HIGH, WHICH RESULTED IN A BURNING SENSATION AT HIS LEAD SITE. A SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. FOLLOW-UP INFORMATION IDENTIFIED THE PATIENT'S LEADS WERE REPLACED WITH NEW ONES. THE PATIENT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3741506

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788