BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2230428 · Received August 15, 2011

    Report

    Report Number
    1627487-2011-05031
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    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 PERCUTANEOUS LEADS (FROM SAME LOT) FOR AN SCS TRIAL ON (B)(6) 2011. IT WAS REPORTED THAT DURING THE TRIAL THERE WAS A WET TAP. AFTER THE LEAD WAS PLACED THE PT COMPLAINED OF PAIN IN HER FOOT. THE PHYSICIAN SAID IT WAS NERVE FOOT PAIN. THE PT WAS PROGRAMMED AND WENT HOME. THE PAIN PERSISTED AND THE NEXT DAY THE LEADS WERE PULLED AND THE TRIAL ENDED. THE PHYSICIAN ADVISED THAT THERE WAS NO SPECIFIC DIAGNOSIS PERTAINING TO THIS EVENT. THE SYMPTOMS ARE CURRENTLY PARTIALLY RESOLVED AND APPEAR TO BE TEMPORARY. THERE WERE NO IMAGING STUDIES CONDUCTED AFTER THE ONSET OF SYMPTOMS AND NO FURTHER INTERVENTION HAS BEEN CONDUCTED. THE PHYSICIAN IMPLIED THAT THE PT'S SYMPTOMS WERE NOT DEVICE RELATED. THE NEXT PLAN OF ACTION FOR THE PT IS TO ALLOW HER ONE MONTH TO RECOVER AND THEN CONDUCT A RE-TRIAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3389144

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention