BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT PDS3000 6PK PILLAR PALATAL EN

    MDR report key: 2800863 · Received October 17, 2012

    Report

    Report Number
    1045254-2012-00475
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 10, 2009
    Report Date
    September 11, 2009
    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

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE MANUFACTURED BY RESTORE MEDICAL, WHICH WAS SUBSEQUENTLY PURCHASED BY MEDTRONIC XOMED - THE MANUFACTURE DATE OF THIS DEVICE IS NOT AVAILABLE. RESULTS - NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. THE IMPLANT 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). THE SYSTEM CONSISTS OF A DELIVERY TOOL AND AN IMPLANT. THE DELIVERY TOOL COMES PRELOADED WITH THE IMPLANT. THE IMPLANT ISA BRAIDED SEGMENT OF POLYESTER FILAMENTS INTENDED FOR PERMANENT IMPLANTATION. 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 A 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. USE OF THE IMPLANT 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 RELATIONSHIP OF THE DEVICE TO THE REPORTED INCIDENT IS UNCLEAR. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND NOT RETURNED TO THE MANUFACTURER; THEREFORE, NO PRODUCT ANALYSIS IS AVAILABLE. WITHOUT RETURN OF THE DEVICE, IT CANNOT BE DETERMINED WHETHER OR NOT IT FAILED TO MEET SPECIFICATION. NO APPLICABLE IMAGING FILMS OR MEDICAL RECORDS WERE RECEIVED. NO PATIENT INFORMATION/IDENTIFIER WAS SUBMITTED WITH THE ORIGINAL REPORT, WITHOUT WHICH IT IS NOT POSSIBLE TO FOLLOW-UP WITH THE CLINICIAN FOR ANY MISSING DATA. THEREFORE, THE AVAILABLE INFORMATION IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. INFORMATION RECEIVED REASONABLY SUGGESTS SERIOUS INJURY, OR MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY, THUS WE ARE FILING THIS REPORT AS AN ADVERSE EVENT AND PRODUCT PROBLEM.

    Description of Event or Problem · 1

    THIS REPORT IS PROVIDED TO YOU AS A PART OF A RETROSPECTIVE REVIEW, PER DISCUSSION WITH OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB), AND WAS PERFORMED AS THE RESULT OF RECENT CHANGES/IMPROVEMENTS MADE TO PRODUCT SPECIFIC CRITERIA DEVELOPED BY MEDTRONIC XOMED RELATED TO OUR PILLAR PALATIAL IMPLANTS TO MAKE MEDICAL DEVICE REPORT (MDR) DECISIONS. IT WAS REPORTED BY THE PHYSICIAN THAT 1 PROSTHESIS PALATAL (BRAIDED POLYESTER FILAMENT) IMPLANT PARTIALLY POKED THROUGH THE MUCOSA (24 HOURS POST PROCEDURE). THE IMPLANT WAS REMOVED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT PDS3000 6PK PILLAR PALATAL EN LRK - DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC. PDS3000 8205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention