BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDE SPACED QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1910287 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03580
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 4. EVALUATION: THE REPORTED COMPLAINT CANNOT BE CONFIRMED THROUGH VISUAL, PERFORMANCE OR FUNCTIONAL TESTING. AS A RESULT, NO TESTING ON THE RETURNED PRODUCTS WAS PERFORMED. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED COMPLAINT. 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

    DEVICE 1 OF 4. REFERENCE MANUFACTURER REPORTS: 1627487-2010-03581, 1627487-2010-03582 AND 1627487-2010-03583. THE PATIENT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG AND THREE PERCUTANEOUS LEADS, ON (B)(6) 2010. IT WAS REPORTED THE PATIENT COMPLAINED OF PERSISTENT BURNING AT THE LEAD IMPLANT SITES AND STIMULATION IN INAPPROPRIATE LOCATIONS. AS THE PATIENT WAS NOT GETTING THE COVERAGE NEEDED FROM THE SCS SYSTEM, THE PHYSICIAN OPTED TO PERFORM A LEAD REVISION PROCEDURE. WHEN THE IPG POCKET WAS OPENED, THE PHYSICIAN DISCOVERED THE PATIENT HAD DEVELOPED A LARGE SEROMA. THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED; HOWEVER, THE PHYSICIAN INDICATED THE SYSTEM WOULD BE REPLACED IN THE FUTURE. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIDE SPACED QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 2890980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention