BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931842 · Received June 20, 2014

    Report

    Report Number
    1627487-2014-02447
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    March 1, 2013
    Report Date
    May 27, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: OPTICAL INSPECTION OF THE RETURNED LEADS REVEALED BROKEN WIRES AT APPROX 13.0CM FROM THE STIMULATION ENDS. THE OTHER LEAD HAD BROKEN WIRES AT APPROX 9.5CM FROM THE STIMULATION END. THE BROKEN WIRES IN THE LEAD BODIES WERE CONSISTENT WITH THE OVERSTRESS CONDITIONS THE LEADS WERE SUBJECTED TO WHILE IMPLANTED. 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2014-06111, 02446.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364307 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3444720

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (X2)