BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16SURGICAL LEAD

    MDR report key: 1883179 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-03030
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: 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. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 RECEIVED HER SCS SYSTEM ON (B)(6) 2008, CONSISTING OF AN IPG, LEAD AND TWO EXTENSIONS. THE LEAD WAS SECURED USING AN ANCHOR. IT WAS REPORTED THAT THE PT SUDDENLY LOST STIMULATION DURING A RECENT RECREATIONAL ACTIVITY. DIAGNOSTIC TEST ON THE LEAD REVEALED HIGH IMPEDANCE READINGS. X-RAYS WERE ALSO TAKEN; HOWEVER, NO VISIBLE ABNORMALITIES WERE DETECTED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET. A SUPPLEMENTAL REPORT WILL BE FILED AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3219 174652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention