BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032030 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-02421
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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

    THE PATIENT UNDERWENT A PROCEDURE FOR A PERMANENT SCS SYSTEM. IT WAS REPORTED THE PATIENT JUMPED AND REPORTED SUDDEN PAIN IN HER RIGHT LEG WHEN THE SECOND LEAD WAS IMPLANTED. ALLEGEDLY, THE PHYSICIAN HAD DIFFICULTY PLACING THE SECOND LEAD DUE TO THE PATIENT'S ANATOMY AND APPROXIMATELY 6 ATTEMPTS WERE MADE BEFORE THE LEAD WAS IMPLANTED. IT WAS REPORTED THE PATIENT CONTINUED TO COMPLAIN OF RIGHT LEG PAIN DURING INTRAOPERATIVE TESTING. THE PHYSICIAN DECIDED TO REMOVE THE SECOND LEAD. THE PATIENT CONTINUED TO REPORT RIGHT LEG PAIN POSTOPERATIVE. FOLLOW-UP INDICATED THE RIGHT LEG PAIN HAD RESOLVED ON (B)(6) 2013. IT WAS REPORTED THE PATIENT WILL MEET WITH THE SJM REPRESENTATIVE AT A LATER DATE TO ATTEMPT PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123212 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3845100

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3688