BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD KIT

    MDR report key: 1904125 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02360
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 10, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    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

    EVALUATION: RESULTS: LEAD SEVERELY KINKED. (B)(4). 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 RECEIVED HER SCS SYSTEM ON AN UNKNOWN DATE. THE PATIENT WAS IMPLANTED WITH TWO SCS SYSTEMS. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION. TWO OF THE LEADS WERE REPLACED ON (B)(6) 2008. THE EXPLANTED LEADS WERE RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD KIT SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention