BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 3232814 · Received July 18, 2013

    Report

    Report Number
    1045254-2013-00460
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. E: INITIAL REPORTER IS THE PATIENT, AND MEDTRONIC HAS THIS INFORMATION ON FILE. (B)(4). EXPLANT WAS DISCARDED. THE PATIENT STATED SHE HAD THREE SINUS SURGERIES IN 2010-2011 AND DURING THE LAST SURGERY; A SECOND PILLAR IMPLANT WAS REMOVED. THIS EVENT WILL BE FILED UNDER A SEPARATE MDR, WITH THE PATIENT IDENTIFIER AS (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT, SHE HAD A PILLAR PROCEDURE WITH 3 IMPLANTS AND AN UVULECTOMY LATE IN 2009. A WEEK AFTER THE PROCEDURE, SHE FELT SOMETHING IN HER THROAT, SHE WENT BACK TO THE SURGEON, WHO REMOVED AN EXTRUDING PILLAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333111 IMPLANT PDS3000M 6PK PILLAR PALATAL DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC. PDS3000M NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1