BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03294

    MDR report key: 3161313 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03294
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH VEPTR ON AN UNSPECIFIED DATE. REPORTEDLY THE DEVICE WAS RUBBING AND CAUSING THE PRESSURE ON THE PATIENTS SKIN. IT WAS REPORTED THE PATIENT WAS THIN. THE VEPTR WAS PROMINENT AND THE PATIENTS SKIN WAS BREAKING DOWN. THE SURGEON MONITORED THE PATIENT AND APPROXIMATELY TWO WEEKS LATER, THE SURGEON DECIDED TO KEEP THE DEVICE IMPLANTED DUE TO HER SKIN ADAPTING TO THE SURGERY. REPORTEDLY THE PATIENTS SKIN AROUND THE IMPLANT IS IMPROVING AND THERE IS NO NEED TO REMOVE THE IMPLANT. SURGEON WANTS TO KEEP THE VEPTR IMPLANTED DUE TO IMPROVED POST SURGICAL RESPIRATORY FUNCTION FROM VEPTR. THERE WAS NO REPORTED ISSUE WITH THE IMPLANT FUNCTION; HOWEVER, THE PATIENTS SKIN WAS NOT TOLERATING THE IMPLANTS DUE TO HER WEIGHT AND SIZE. THE SURGEON DETERMINED SHE WAS IMPROVING AND THE PATIENTS MOTHER WANTS TO KEEP IN THE DEVICE DUE TO IMPROVED BREATHING FROM HER CHILD. THIS REPORT IS FOR AN UNKNOWN VEPTR IMPLANT. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262876 MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention