BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCARE BLADDER SYSTEM

    MDR report key: 379542 · Received March 1, 2002

    Report

    Report Number
    1530440-2002-00002
    Event Type
    Injury
    Date Received
    March 1, 2002
    Date of Event
    January 1, 2002
    Report Date
    February 28, 2002
    Manufacturer
    NEUROCONTROL CORP.
    Product Code
    GZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS IMPLANTED WITH THE VOCARE BLADDER SYSTEM IN 2002, AND EXPERIENCED HIGH RESIDUALS POST-IMPLANTATION. APPROXIMATELY ONE MONTH FOLLOWING DEVICE IMPLANTATION, THE PATIENT UNDERWENT A PROCEDURE TO REPOSITION THE EXTRADURAL ELECTRODE AND TIE IT CLOSER TO THE NERVE ROOT. THE RESPONSE WAS IMPROVED INTRAOPERATIVELY, BUT POOR RESPONSE WAS AGAIN EXPERIENCED POST-OPERATIVELY. THE SAME WEEK, ANOTHER SURGERY WAS PERFORMED IN WHICH A NICK IN THE INSULATION OF THE LEAD WAS OBSERVED. AT THIS TIME, A NEW ELECTRODE WAS IMPLANTED TO REPLACE THE MALFUNCTIONING ELECTRODE. THE ORIGINAL ELECTRODE WAS LEFT IMPLANTED WITH THE NEW ELECTRODE CONNECTED TO THE IMPLANTED STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCARE BLADDER SYSTEM IMPLANTABLE STIMULATOR FOR BLADDER EVACUATION GZC NEUROCONTROL CORP. 1640-1/1641-1 1138/1139

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention