BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANS RENEW 16-CHANNEL RECEIVER

    MDR report key: 597517 · Received April 28, 2005

    Report

    Report Number
    1627487-2005-00002
    Event Type
    Other
    Date Received
    April 28, 2005
    Date of Event
    February 6, 2005
    Report Date
    March 29, 2005
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED IN 2005. PT DEVELOPED AN INFECTION AND WAITED 7-10 DAYS TO REPORT IT TO PHYSICIAN. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND THEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS RENEW 16-CHANNEL RECEIVER SPINAL CORD STIMULATOR RECEIVER GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3416 34012A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other