BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 88C PADDLE LEAD

    MDR report key: 1790855 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01630
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    September 8, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEAD IS KINKED WITH ALL WIRES BROKEN IN THE 1-8 CHANNEL LEAD SEGMENT APPROX 12 CM FROM THE PADDLE END. THE LEAD HAS WIRES BROKEN IN THE 9-16 CHANNEL LEAD SEGMENT APPROX 12.5 CM FROM THE PADDLE END. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYSTEM INCLUDING A PADDLE LEAD ON (B)(6) 2006. IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF STIMULATION; THAT HE WAS NO LONGER RECEIVING THE DESIRED BILATERAL STIMULATION. DIAGNOSTIC TESTING SHOWED HIGH AND INVALID IMPEDANCES ON ALL BUT 4 CONTACTS. THE LEAD WAS REPLACED ON (B)(6) 2008. THE EXPLANTED LEAD WAS RETURNED TO ANS FOR ANALYSIS. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88C PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3289 57017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention