BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44C SURGICAL LEAD

    MDR report key: 2142112 · Received May 25, 2011

    Report

    Report Number
    1627487-2011-02656
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEURMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL ANALYSIS FOUND DISCOLORATION IN THE LEAD WITH ALL WIRES BROKEN IN THE PADDLE. DUE TO THE CONDITION OF THE RETURNED LEAD, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-02504.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEURMODULATION 3245 2898530

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192| SCS LEAD: MODEL 3183