BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD, 30CM LENGTH

    MDR report key: 2190807 · Received July 26, 2011

    Report

    Report Number
    1627487-2011-06028
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K022222
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: AS RECEIVED, THE LEAD FAILED CONTINUITY TESTING AS ALL CHANNELS MEASURED INVALID. MICROSCOPIC INSPECTION OF THE RETURNED LEAD REVEALED FLUID INTRUSION NEAR THE TERMINAL END. THE CHANNEL 1 WIRE WAS OBSERVED DISCONNECTED FROM THE CHANNEL 1 STIMULATION ELECTRODE. IN ADDITION, A PERMANENT BEND IN THE LEAD WIRES WAS OBSERVED AT APPROX 22CM FROM THE STIMULATION END; HOWEVER, THE WIRES WERE NOT BROKEN AT THIS LOCATION. 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 SURGICAL LEAD ON (B)(6) 2010. 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 REPLACE THE PT'S LEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD, 30CM LENGTH SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3283 2861790

    Patients

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