BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELETRACE

    MDR report key: 2203513 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01234
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER INDICATED THAT THE TRANSTELEPHONIC MONITOR (TTM) HAS BEEN GETTING "MORE AND MORE NOISY." THE PRODUCT REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELETRACE PATIENT MONITORING INSTRUMENT NVZ MEDTRONIC, INC. 9531W ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other