BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT

    MDR report key: 4200725 · Received October 24, 2014

    Report

    Report Number
    1045254-2014-00273
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICE WAS RECEIVED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED. (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    EVENT 1: IT WAS REPORTED THAT A MALE PATIENT PRESENTED TO (B)(6) HOSPITAL ER IN 2011 FOR TONGUE SWELLING. A CT SCAN WAS PERFORMED AND HE WAS TREATED WITH ANTIBIOTICS AND STEROIDS AS AN OUTPATIENT. HE RESPONDED PROMPTLY TO TREATMENT AND LATER FOLLOWED-UP WITH HIS ENT PHYSICIAN. (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4); THE REGULATORY REPORT NUMBER WAS NOT AVAILABLE AT THE TIME OF SUBMISSION) EVENT 2 <(>&<)> 3: IT WAS REPORTED THAT A MALE PATIENT COMPLAINED OF TONGUE SWELLING. HE WAS TREATED WITH ORAL ANTIBIOTICS AND STEROIDS BY HIS PRIMARY CARE PHYSICIAN AS AN OUTPATIENT. (EVENT 3: THE SUBJECT OF THIS REGULATORY REPORT; EVENT 2: MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4) - THE REGULATORY REPORT NUMBER WAS NOT AVAILABLE AT THE TIME OF SUBMISSION) EVENT 4: IT WAS REPORTED THAT A MALE PATIENT OF APPROXIMATELY (B)(6) YEARS IN AGE COMPLAINED OF PAIN, TONGUE SWELLING AND DYSPHAGIA WHICH WORSENED DESPITE TREATMENT WITH ANTIBIOTICS AND STEROIDS. THE PATIENT WAS ADMITTED TO THE (B)(6) HOSPITAL ON (B)(6) 2014, WHERE HE WAS GIVEN IV ANTIBIOTICS AND STEROIDS. A CT SCAN WAS ALSO PERFORMED AND DEMONSTRATED A LUCENCY IN THE BASE OF HIS TONGUE THAT WAS SIGNIFICANTLY LARGER THAN WHEN COMPARED TO HIS 2011 CT. HE HAD MARKED ELEVATION OF HIS WHITE BLOOD CELL COUNT (24,000) AND WAS UNABLE TO SWALLOW HIS OWN SECRETIONS. HE WAS TAKEN TO THE OPERATING ROOM AS A RESULT AND AN AWAKE FIBEROPTIC INTUBATION WAS PERFORMED DUE TO HIS TENUOUS AIRWAY. ASPIRATION OF HIS TONGUE BASE REVEALED 10CC PUS AND EXPLORATION OF HIS NECK REVEALED A MEDTRONIC REPOSE BONE SCREW WHICH WAS IMPLANTED IN 2003 OR 2004, WAS NOT SECURED TO THE MANDIBLE BUT INSTEAD LOOSE WITHIN THE SOFT TISSUE. THE SCREW WAS REMOVED ALONG WITH ITS ATTACHED SUTURE¿IT WAS NOTED THAT THE ¿LOOP¿ PORTION OF THE SUTURE WAS COATED WITH PURULENCE AND WAS SENT TO THE PATHOLOGY DEPARTMENT. THE PATIENT WAS OBSERVED ONE NIGHT IN THE ICU FOR AIRWAY CONCERNS, AND WAS DISCHARGED POST-OPERATIVELY ON THE 2ND DAY. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS ¿DOING WELL¿. (REGULATORY REPORT #1045254-2014-00264)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679690 AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED INC. 76353200M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention