BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2492703 · Received March 9, 2012

    Report

    Report Number
    1045254-2012-00061
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    October 19, 2009
    Report Date
    November 18, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PTS SUFFERING FROM MILD TO MODERATE OBSTRUCTIVE SLEEP APNEA (OSA). 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 SYS CONSISTS OF 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 (18 MM) IN LENGTH AND HAS AN APPROX 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. DEVICE IS NOT SERIALIZED. AS NO LOT NUMBER WAS PROVIDED, THE EXP DATE COULD NOT BE DETERMINED. AS NO LOT NUMBER WAS PROVIDED, THE MANUFACTURE DATE COULD NOT BE DETERMINED.

    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 (OBS), AND WAS PERFORMED AS THE RESULT OF RECENT CHANGES/IMPROVEMENTS MADE TO PRODUCT SPECIFIC CRITERIA DEVELOPED BY MEDTRONIC XOMED RELATED TO OUR PILLAR PALATAL IMPLANTS TO MAKE MEDICAL DEVICE REPORT (MDR) DECISIONS. ADDITIONALLY, THIS CHANGE/IMPROVEMENT, WHICH WAS INITIATED IN JAN 2012, HAS RESULTED IN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC XOMED. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF ANY NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE SUBMISSION CRITERIA WITHIN OUR PROCESS. IT WAS REPORTED THAT AN IMPLANT EXTRUSION OCCURRED MORE THAN 24 HOURS AFTER THE PROCEDURE. THERE WAS NO SAMPLE RETURNED AND NO PT INJURY REPORTED. IN ADDITION, THE EVENT DESCRIPTION IS EXPANDED TO INCLUDE THE DETAILS OF THE ATTACHED PILLAR PALATAL IMPLANT SYS FEEDBACK FORM IN WHICH THE PHYSICIAN STATED: THE PT EXPERIENCED "FOREIGN BODY SENSATION" AND THE IMPLANT PARTIALLY POKES THROUGH THE MUCOSA, MORE THAN 24 HOURS POST PROCEDURE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1