BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3031969 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15415
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH TWO LEADS (FROM THE SAME LOT) AS PART OF HIS SCS TRIAL SYSTEM. IT WAS REPORTED THE PT EXPERIENCED INCREASED PAIN IN HIS RIGHT ARM DURING HIS SCS SYSTEM TRIAL. THE PT'S RIGHT ARM AND HAND APPEARED SWOLLEN, RED AND SENSITIVE. THE PHYSICIAN REMOVED THE RIGHT MOST TRIAL LEAD AND THE PT'S ARM IMMEDIATELY IMPROVED. THE SWELLING AND DISCOLORATION IMPROVED AFTER A SHORT PERIOD OF TIME. THE PHYSICIAN INDICATED HE BELIEVED THE LEAD WAS APPLYING PRESSURE TO THE NERVE IN THE RIGHT ARM. THE SJM REP ATTEMPTED TO PROGRAM THE REMAINING LEAD, BUT WAS UNABLE TO PROVIDE COVERAGE AND THE PT REQUESTED THE LEAD BE REMOVED. THE PHYSICIAN THEN REMOVED THE SECOND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128652 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3846753

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention