BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3031928 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-00187
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 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 - VISUAL INSPECTION OF THE RETURNED LEADS REVEALED THE LEADS WERE COMPLETELY AND CLEANLY CUT INTO TWO STIMULATION END SEGMENTS AND TWO TERMINAL END SEGMENTS CONSISTENT WITH EXPLANT DAMAGE. A BENT AREA WITH ALL WIRES BROKEN WAS OBSERVED ON BOTH OF THE STIM END SEGMENTS. NO SWIFT-LOCK ANCHOR CAM MARKS WERE IDENTIFIED IN THE AREA OF THE BEND AND BROKEN WIRES; THEREFORE, THIS DAMAGE WAS NOT ASSOCIATED WITH THE ANCHOR. THE OUTER TUBING WAS NOT BREACHED AT THE BENT LOCATION; THEREFORE, THE HARD BEND, AND BROKEN WIRE DAMAGE IS CONSISTENT TO A LOCALIZED REPETITIVE OVERSTRESS CONDITION ENCOUNTERED OVER TIME WHILE THE LEADS WERE IN THE PATIENT. 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 3 OF 3: REFERENCE MFR REPORT#S 1627487-2011-02831 AND 1627487-2013-00186.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128464 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3071332

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention