BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1910946 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03232
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. MARKS CONSISTENT WITH ELECTROSURGERY INSTRUMENTATIONS WERE OBSERVED ON BOTH LEADS. 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 3 OF 5. REFERENCE MANUFACTURER REPORTS: 1627487-2010-03230, 1627487-2010-03231, 1627487-2010-03299 AND 1627487-2010-03300. THE PT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG, FOUR PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), AND TWO EXTENSIONS (FROM TWO SEPARATE LOTS) ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING EFFECTIVE PAIN COVERAGE FROM THE STIMULATION. THE PHYSICIAN EXPLANTED THE SYSTEM ON (B)(6) 2010. THE DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVAL ON (B)(6) 2010. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3166 2898526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention