BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCARE BLADDER SYSTEM

    MDR report key: 302604 · Received November 1, 2000

    Report

    Report Number
    1530440-2000-00011
    Event Type
    Injury
    Date Received
    November 1, 2000
    Date of Event
    May 17, 2000
    Report Date
    July 24, 2000
    Manufacturer
    FINETECH MEDICAL LTD.
    Product Code
    GZC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    B2: PT IS UNABLE TO USE DEVICE AS INTENDED DUE TO INCOMPLETE PROCEDURE PERFORMED IN CONJUNCTIION WITH IMPLANTATION PROCEDURE FOR DEVICE. PT WAS IMPLANTED WITH THE VOCARE BLADDER SYSTEM IN 2000. ONE MONTH LATER, PT WAS EXPERIENCING AUTONOMIC DYSREFLEXIA SYMPTOMS INDICATING AN INCOMPLETE RHIZOTOMY. IT WAS LATER DETERMINED THAT THE RHIZOTOMY PROCEDURE THAT IS NORMALLY PERFORMED IN CONJUNCTION WITH THE IMPLANTATION OF THE DEVICE WAS INCOMPLETE. PT WILL HAVE TO UNDERGO ADD'L SURGERY IN ORDER TO COMPLETE THE RHIZOTOMY PROCEDURE TO ENSURE THAT THE VOCARE BLADDER SYSTEM CAN FUNCTION AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCARE BLADDER SYSTEM IMPLANTABLE NEUROSTIMULATION DEVICE GZC FINETECH MEDICAL LTD. (IN U.S. = 1640) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other