BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTOLOGY VENT TUBE

    MDR report key: 6778438 · Received August 9, 2017

    Report

    Report Number
    1045254-2017-00275
    Event Type
    Injury
    Date Received
    August 9, 2017
    Report Date
    July 13, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLINE LINK TO ARTICLE: HTTP://WWW.IJPORLONLINE.COM/ARTICLE/S0165-5876(16)30466-9/FULLTEXT. PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    RESULTS REPORTED IN ¿HEARING SENSITIVITY IN ADULTS WITH A UNILATERAL CLEFT LIP AND PALATE AFTER TWO-STAGE PALATOPLASTY¿, I.F.P.M. KAPPEN, ET AL., INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY 94 (2017) 76-81. ¿OBJECTIVE: TO EVALUATE LONG-TERM HEARING AND MIDDLE EAR STATUS IN PATIENTS TREATED FOR A UNILATERAL COMPLETE CLEFT LIP AND PALATE (UCLP) BY TWO-STAGE PALATOPLASTY.¿ THIS STUDY FOUND ¿A POSITIVE CORRELATION BETWEEN THE FREQUENCY OF TUBE INSERTION AND HEARING LOSS WAS OBSERVED, INDICATED BY THE PTA FOR AIR CONDUCTION (0.435, P = 0.001). THERE WAS A SIGNIFICANTLY HIGHER PHARYNGOPLASTY INCIDENCE IN THE GROUP THAT HAD RECEIVED VENTILATION TUBES (P = 0.013).¿ ¿ABNORMAL EARDRUM COMPLIANCE, WHICH WAS ASSOCIATED WITH VT INSERTION IN OUR SERIES, MAY THEREFORE CONTRIBUTE TO THE HEARING LOSS OBSERVED WITHIN OUR GROUP. BECAUSE OF THE MULTIFACTORIAL CAUSE OF HEARING LOSS IN UCLP PATIENTS, IT REMAINS HOWEVER DIFFICULT TO ASSESS TO WHAT EXTENT VT INSERTION CONTRIBUTES TO THE INCIDENCE OF HL. INFLAMMATORY ASSOCIATED MIDDLE EAR DAMAGE ALSO HAS A ROLE.¿ ¿OUR HIGH INCIDENCE OF VELOPHARYNGEAL INCOMPETENCE DURING EARLY CHILDHOOD, WHICH IS LIKELY ASSOCIATED WITH EUSTACHIAN TUBE DYSFUNCTION, MIGHT HAVE CONTRIBUTED TO THESE RESULTS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559681 OTOLOGY VENT TUBE TUBE, TYMPANOSTOMY ETD MEDTRONIC XOMED INC. XOM UNK OTOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability