BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 30CM LENGTH

    MDR report key: 2210418 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-06047
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: AS RECEIVED THE LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROXIMATELY 9CM FROM THE STIMULATION END. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE BROKEN WIRES IN THE LEAD SEGMENT. MOST LIKELY STRESS INDUCED WHILE THE DEVICE WAS 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

    THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO ADDRESS THIS ISSUE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE PT'S LEAD WAS FRACTURED. THE DEVICE WAS REPLACED AND EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 30CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3208997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL UNK| IMPLANT DATE: