BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2926095 · Received January 17, 2013

    Report

    Report Number
    1627487-2013-02106
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    August 27, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    RESULTS: THE LEADS WERE RETURNED WITH INSTRUMENTATION DAMAGE AND CAM IMPRESSIONS ON THE OUTER TUBING. CONTINUITY TESTING OF THE LEADS REVEALED ELECTRICAL OPENS ON MULTIPLE CHANNELS; LEAD "A", CHANNEL 1 AND LEAD "B", CHANNELS 5 AND 7. NO BROKEN WIRES WERE VISIBLE BUT STRESSING THE LEAD ISOLATED ONE OF THE OPENS TO THE TERMINAL END. 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 2 OF 3. REFERENCE MFR REPORTS: 1627487-2012-02334 AND 02107.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25528 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3497986

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention