BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE 8 EXTENSION

    MDR report key: 1904282 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02145
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    August 5, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 HIS SCS SYSTEM ON (B)(6) 2006. ON (B)(6) 2007, THERE WAS A REVISION OF THE PATIENT'S LEAD THAT IS DOCUMENTED IN MDR 1627487-2010-01145. ON (B)(6) 2008, IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING STIMULATION AT MAXIMUM AMPLITUDE. THE EXTENSION WAS EXPLANTED AND REPLACED ON AN UNKNOWN DATE. THE EXTENSION WAS NOT RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3383

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention