BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3252158 · Received July 25, 2013

    Report

    Report Number
    1627487-2013-06674
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    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 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 NUMBER. IT WS REPORTED THE PT COMPLAINED SHE WAS NO LONGER RECEIVING ANY PAIN RELIEF FROM HER STIMULATION. THE PT WAS REPROGRAMMED MULTIPLE TIMES AND EFFECTIVE STIMULATION COVERAGE WOULD BE OBTAINED BUT IT WOULD NOT LAST. THE PT IS SCHEDULED TO HAVE HER SCS SYSTEM REMOVED. FOLLOW-UP IDENTIFIED THE PT HAD HER ENTIRE SCS SYSTEM REMOVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348301 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3117518

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other SCS ANCHOR: MODEL 1192 (X2)| IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788