BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE SURGICAL LEAD

    MDR report key: 1884081 · Received October 21, 2010

    Report

    Report Number
    1627487-2010-03015
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 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 RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. THE PATIENT REPORTED FEELING SLIGHT ABDOMINAL TENDERNESS AND CRAMPING IMMEDIATELY FOLLOWING THE PROCEDURE. OVER TIME, THE PATIENT ALLEGED, THE PAIN IN HER ABDOMEN BECAME PROGRESSIVELY WORSE. AS THE PHYSICIAN SUSPECTED THE IMPLANT SPACE WAS TOO SMALL, A SECOND LAMINECTOMY PROCEDURE WAS PERFORMED AT T10 AND T11 AND THE LEAD WAS REPOSITIONED. FOLLOW UP ON THE PATIENT FOUND THAT HER SYMPTOMS HAVE SUBSIDED SINCE THE SECOND PROCEDURE. AS THE PRODUCTS REMAIN IN USE, NO RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3087989

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R