BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANS RENEW 16 CHANNEL RECEIVER

    MDR report key: 538819 · Received August 13, 2004

    Report

    Report Number
    1627487-2004-00002
    Event Type
    Other
    Date Received
    August 13, 2004
    Date of Event
    May 4, 2004
    Report Date
    June 1, 2004
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED IN 2004. PT PRESENTED PURULENT DRAINAGE FROM BOTH INCISIONS (RECEIVER SITE AND LAD ANCHOR SITE). PT HAD PAIN AND FEVER. PT WAS EXPLANTED IN 2004.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other