BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1904283 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02158
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. LEAD SEVERELY KINKED WITH WIRES BROKEN. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT (FRANCE) RECEIVED THEIR SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE LEAD GAVE INVALID IMPEDANCE MEASUREMENTS. THE LEAD WAS EXPLANTED ON (B)(6) 2009. THE EXPLANTED LEAD WAS SENT BACK TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3153 113349

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention