BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792158 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-03496
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    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

    EVALUATION: RESULTS: THE 3086 LEAD AND ACCESSORIES WERE VISUALLY EXAMINED UNDER THE MICROSCOPE NO VISUAL ANOMALIES OR DAMAGE WAS OBSERVED. CONTINUITY TESTING WAS PERFORMED WHILE TWISTING, BENDING, AND STRETCHING THE LEADS AND NO ANOMALIES WERE OBSERVED. ALL THE CHANNELS MEASURED LESS THAN 4 OHMS AS INDICATED IN DOCUMENT (B)(4). THE CHANNELS MEASURED THE FOLLOWING. CONCLUSION: THE COMPLAINT: "INVALID IMPEDANCE" COULD NOT BE CONFIRMED; THE LEAD AS RETURNED WAS EXAMINED UNDER THE MICROSCOPE AND NO VISUAL ANOMALY WAS OBSERVED. LEAD PASSES ALL FUNCTIONAL TESTS. SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED DURING THE TRIAL PROCEDURE THE SCS LEAD SHOWED INVALID IMPEDANCE VALUES. THE SCS LEAD WAS REPLACED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3764986

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention