BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT

    MDR report key: 1904074 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02359
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    August 26, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT ((B)(6)) REC'D THEIR SCS SYSTEM ON AN UNK DATE. IT WAS REPORTED THAT THE LEAD MIGRATED AND GAVE INVALID IMPEDANCE READINGS DURING THE REVISION PROCEDURE. THE LEAD WAS REPLACED AND RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention