BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCARE SARS

    MDR report key: 304716 · Received November 14, 2000

    Report

    Report Number
    1530440-2000-00012
    Event Type
    Malfunction
    Date Received
    November 14, 2000
    Date of Event
    October 13, 2000
    Manufacturer
    FINETECH MEDICAL LTD.
    Product Code
    GZC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH THE VOCARE SARS SYSTEM IN AUSTRALIA. THE PT CANNOT USE THE DEVICE BECAUSE THE SYSTEM STOPPED FUNCTIONING. THE EXACT CAUSE OF THE MALFUNCTION CANNOT BE DETERMINED WITHOUT SURGERY. THERE IS NO PLAN AT THE PRESENT FOR REPLACEMENT. NO REPORT OF ANY PATIENT INJURY ASSOCIATED TO THE DEVICE. B2: PATIENT IS UNABLE TO USE DEVICE AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCARE SARS IMPLANTABLE NEUROSTIMULATION DEVICE GZC FINETECH MEDICAL LTD. 1640-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other