BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCLAIM 8 SURGICAL LEAD

    MDR report key: 1883162 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-03029
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 WAS IMPLANTED WITH TWO SURGICAL LEADS ON (B)(6) 2008, IT WAS REPORTED THAT THE PT'S LEADS WERE NOT FUNCTIONAL, AND THE PT WAS SUDDENLY RECEIVING STOMACH STIMULATION. AN X-RAY REVEALED THAT THE DEVICES HAD MIGRATED AND WERE BENT. THE PHYSICIAN REMOVED AND REPLACED THE PT'S LEADS ON (B)(6) 2010. F/U ON THE PT FOUND THAT HE IS NOW RECEIVING EFFECTIVE STIMULATION; NO ADDITIONAL ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3224 171381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention