BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCARE BLADDER SYSTEM

    MDR report key: 444504 · Received February 26, 2003

    Report

    Report Number
    1530440-2003-00002
    Event Type
    Injury
    Date Received
    February 26, 2003
    Report Date
    February 26, 2003
    Manufacturer
    NEUROCONTROL CORP
    Product Code
    GZC
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH VOCARE BLADDER SYSTEM IN 2001. INFLAMMATION AT SITE OF IMPLANTED STIMULATOR AND CABLE NOTED DURING FIRST WEEK AFTER IMPLANT. PT WAS TREATED WITH INTRAVENOUS VANCOMYCIN FOR 5 WEEKS AND INFLAMMATION HAS SINCE RESOLVED. PT IS USING THE VOCARE BLADDER SYSTEM. THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCARE BLADDER SYSTEM SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL GZC NEUROCONTROL CORP 1904 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN