BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931878 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-00359
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    January 14, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: COMPLAINT WAS VISUALLY CONFIRMED FOR "LEAD BROKEN/FRACTURED." AS RECEIVED, THE LEAD HAD BREAKAGE WITH ALL WIRES BROKEN. THE LEAD APPEARED TO BE SUBJECTED TO STRESS WHILE IMPLANTED IN THE PATIENT'S BODY. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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

    IT WAS REPORTED THE PATIENT (B)(6) LOST STIMULATION FOLLOWING AN AUTOMOBILE ACCIDENT. SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THIS ISSUE. INTRAOPERATIVE TESTING REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS AND VISUAL INSPECTION OF THE DEVICE FOUND BENDS IN TWO AREAS. AS SUCH, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364216 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3959280

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other