BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1870813 · Received October 6, 2010

    Report

    Report Number
    1627487-2010-02957
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 19, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH AN SCS SYSTEM, WHICH INCLUDED TWO PERCUTANEOUS LEADS AND AN IPG, ON (B)(6) 2010. THE PATIENT REPORTED A CHANGE IN HIS STIMULATION PATTERNS. AN X-RAY OF THE PATIENT'S SYSTEM FOUND THAT ONE OF THE PATIENT'S LEADS HAD MIGRATED FROM T4-T5 TO T11-T12. THE LEAD WAS CAPPED AND REPLACED. AS THE PHYSICIAN OPTED NOT TO EXPLANT THE LEAD, NO PRODUCT RETURN IS ANTICIPATED. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2881379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention