BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3925826 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-15466
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-15467. THE PT UNDERWENT A PROCEDURE FOR A TRIAL SCS SYSTEM AND TWO TRIAL LEADS WERE IMPLANTED. POSTOPERATIVELY, THE PT WAS MOVED FROM THE PRONE TO THE SUPINE POSITION AND BEGAN TO EXPERIENCE PAINFUL TINGLING OF HER LEFT INNER THIGH TO HER KNEE. X-RAYS WERE TAKEN AND INDICATED ONE LEAD HAD MIGRATED. THE PHYSICIAN REMOVED THE TRIAL LEADS AND ONE LEAD WAS FOUND TO BE WRAPPED AROUND LATERAL AT THE ENTRY SITE. AN MRI WAS TO BE ORDERED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED AFTER 3 DAYS. PATIENT CONTINUES TO EXPERIENCE PAIN IN HER LEFT LEG, BUT IT IS IMPROVING. THE PT IS TO UNDERGO PHYSICAL THERAPY AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356441 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4586936

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization