BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032061 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-04374
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    December 28, 2012
    Report Date
    March 5, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2013-04375. THE PT REC'D TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAD SEVERAL REPROGRAMMING SESSIONS, HOWEVER, THE STIMULATION CONTINUED TO BE POSITIONAL. THE PT REPORTED THE STIMULATION CHANGED WHEN LYING DOWN IN DIFFERENT POSITIONS. THE PT ALSO REPORTED THE SCS SYSTEM WAS CAUSING HER TO HAVE STRESS AND ANXIETY. THE PHYSICIAN HAD PRESCRIBED MEDICATION FOR THESE ISSUES. DURING FOLLOW UP IT WAS ALSO REPORTED THE IPG SITE WAS STILL SORE FROM THE IMPLANT, AND THE PT DESCRIBED A BURNING SENSATION THAT WAS PRESENT WITH OR WITHOUT THE SYSTEM IN USE. IT WAS REPORTED THE SENSATION WAS NOT RELATED TO CHARGING THE IPG. THE PT REPORTED IT WAS AN ISSUE WHEN SITTING BACKWARD IN A CHAIR. IT WAS REPORTED THE MAIN CONCERN FOR THE PT WAS THE POSITIONAL STIMULATION, AND THE PT WAS TO BE SENT FOR A CONSULT REGARDING A POSSIBLE SURGICAL LEAD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123839 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3861965

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS EXTENSION: MODEL 3383| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: