BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENEW SINGLE RECEIVER, 8 CHANNEL

    MDR report key: 978063 · Received January 10, 2008

    Report

    Report Number
    1627487-2007-00036
    Event Type
    Other
    Date Received
    January 10, 2008
    Date of Event
    December 10, 2007
    Report Date
    January 10, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS INC
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. ANS INC CORP HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY, AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS INC CORP DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A RENEW RECEIVER IN 2007. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AND HIS ENTIRE SYS WAS EXPLANTED IN LATE 2007. THE PT RECEIVED HIS NEW RENEW RECEIVER SYS IN EARLY 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW SINGLE RECEIVER, 8 CHANNEL IMPLANTABLE SPINAL CORD STIMULATOR LGW ADVANCED NEUROMODULATION SYSTEMS INC 3408 65458

    Patients

    Seq Age Sex Outcome Treatment
    1 Other