BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 2120233 · Received June 7, 2011

    Report

    Report Number
    1627487-2011-01606
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    February 3, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. VISUAL ANALYSIS OF THE LEAD NOTED DISCOLORATION IN THE LEAD SEGMENT AND PADDLE. AS RECEIVED, THE LEAD FAILED CONTINUITY TESTING. TESTING REVEALED THAT SEVERAL CHANNELS MEASURED OPEN. 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 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01605. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2011, FOR LEFT LOWER BACK AND LEG PAIN. IT WAS REPORTED THAT THE PT HAD DEVELOPED A HEMATOMA POSTOPERATIVE. IT WAS REPORTED THAT THERE WAS NO IDENTIFIED DURAL TEAR OR DIFFICULTY WITH LEAD PLACEMENT DURING THE PROCEDURE. THE SYSTEM WAS LEFT IMPLANTED. IT WAS REPORTED THAT THE PT LATER COMPLAINED OF PAIN IN HIS RIGHT GROIN AND LEG, AND HE REPORTED INEFFECTIVE STIMULATION. THE PHYSICIAN DECIDED TO EXPLANT THE SYSTEM ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C SPINAL CORD SITMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 3263237

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention