BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 3014268 · Received February 12, 2013

    Report

    Report Number
    1045254-2013-00089
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    April 2, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. 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). 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 (B)(4) FILAMENTS INTENDED FOR PERMANENT IMPLANTATION. THE IMPLANT IS (B)(4). 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 MFR; 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 PT 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. WITHOUT INFORMATION TO REASONABLY SUGGEST A SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    THE MFR HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: IT WAS REPORTED BY THE PHYSICIAN THAT AN UNK NUMBER OF PILLAR PROSTHESIS PALATAL (BRAIDED (B)(4) FILAMENT) IMPLANTS WERE IMPLANTED INTO THE SOFT PALATE. ONE OF THE IMPLANTS WAS EITHER MISPLACED DURING THE PROCEDURE OR EXTRUDED WITHIN 24 HOURS OF THE PROCEDURE. THE PRODUCT WAS DISCARDED AND THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62714 IMPLANT PDS3000M 6PK PILLAR PALATAL LRK - DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC. PDS3000M 72074200

    Patients

    Seq Age Sex Outcome Treatment
    1