BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2511385 · Received March 30, 2012

    Report

    Report Number
    1045254-2012-00113
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 1, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. NEITHER APPLICABLE IMAGING FILMS NOR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE INFORMATION 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 PATIENTS SUFFERING FROM MILD 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 APPROXIMATELY 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 ACCORDING TO THE PHYSICIAN, THE PATIENT HAD PAIN AND DIFFICULTY SWALLOWING, IMPLANT POKES THROUGH THE MUCOSA 24 HOURS AFTER THE PROCEDURE AND FOREIGN BODY SENSATION; THE IMPLANTS WERE REMOVED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT PDS3000M 6PK PILLAR PALATAL DEVICE, ANTI-SNORING LRK XOMED MFG JACKSONVILLE PDS3000M 0205497015

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention