BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    MDR report key: 2444660 · Received February 9, 2012

    Report

    Report Number
    1045254-2012-00015
    Date Received
    February 9, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 16, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    LRK
    PMA / PMN Number
    K040417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. NEITHER THE DEVICE IN QUESTION, APPLICABLE IMAGING FILMS, OR MEDICAL RECORDS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE, (B)(6, HAD 4 PALATAL IMPLANTS PLACED APPROXIMATELY 4 WEEKS AGO. ACCORDING TO THE PHYSICIAN, IN LESS THAN 24 HRS, THE PATIENT RETURNED COMPLAINING OF PAIN AND DIFFICULTY SWALLOWING DUE TO MISPLACEMENT; THE IMPLANTS NEEDED ADJUSTMENT SO HE MOVED THEM FOR PROPER PLACEMENT. THE PATIENT IS DOING FINE.

    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 0205498247

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention