BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 2121017 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-01633
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT ((B)(6)) WAS UNDERGOING A LEAD REPLACEMENT PROCEDURE (REFERENCE MANUFACTURER REPORT: 1627487-2011-01592) ON (B)(6) 2011. INTRAOPERATIVE TESTING ON THE REPLACEMENT LEAD REVEALED HIGH IMPEDANCE MEASUREMENTS ON TWO LEAD CONTACTS AFTER IMPLANTATION. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD WITH ANOTHER LEAD FROM THE SAME LOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3263526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention