BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2516744 · Received March 30, 2012

    Report

    Report Number
    1045254-2012-00111
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER APPLICABLE IMAGING FILMS NOR MEDICAL RECORDS WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE INFO REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE, IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. INTERVENTION WAS NECESSARY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM/ADVERSE EVENT. DEVICE DESCRIPTION: THE PILLAR SYSTEM IS INTENDED FOR USE IN STIFFENING THE SOFT PALATE TISSUE, WHICH MAY REDUCE THE SEVERITY OF SNORING IN SOME INDIVIDUALS, AND FOR THE REDUCTION OF THE INCIDENCE OF AIRWAY OBSTRUCTIONS IN PTS SUFFERING FROM MID TO MODERATE OBSTRUCTIVE SLEEP APNEA (OSA). USE OF THE SYSTEM INVOLVES POTENTIAL RISKS NORMALLY ASSOCIATED WITH THE USE OF ANY IMPLANTED DEVICE, INCLUDING, BUT NOT LIMITED TO, IMPLANT MIGRATION AND PARTIAL/FULL EXTRUSION OF THE IMPLANT. THE SYSTEM CONSISTS OF A DELIVERY TOOL AND AN IMPLANT. THE DELIVERY TOOL COMES PRELOADED WITH THE IMPLANT. THE IMPLANT IS A BRAIDED SEGMENT OF POLYESTER FILAMENTS INTENDED FOR PERMANENT IMPLANTATION. THE IMPLANT IS APPROX 0.7 INCHES (18MM) IN LENGTH AND HAS AN APPROXIMATE OUTER DIAMETER OF 0.08 INCHES (2 MM). THE DELIVERY TOOL CONSISTS OF A HANDLE AND 14-GAUGE NEEDLE. THE NEEDLE IS INSERTED INTO THE SOFT PALATE; THE IMPLANT IS DEPLOYED BY ADVANCING THE SLIDER; AND THE DELIVERY TOOL IS REMOVED. THE DELIVERY TOOL IS DISPOSABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN IMPLANT MISPLACEMENT OR EXTRUSION THAT OCCURRED WITHIN 24 HOURS OF THE PROCEDURE; THE IMPLANTS WERE REMOVED. THE DEVICE WAS NOT RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT PDS3000M 6PK PILLAR PALATAL LRK - DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC. PDS3000M 0205588390

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention