BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBINSON STAPES PROSTHESIS 0.6 X 4.0MM W/1MM

    MDR report key: 408058 · Received July 30, 2002

    Report

    Report Number
    1045254-2002-00013
    Event Type
    Injury
    Date Received
    July 30, 2002
    Date of Event
    January 14, 2002
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC XOMED RECEIVED A LETTER ON JULY 2002 FROM REPORTER REGARDING A REPORT OF WHAT HE FEELS TO BE A POST STAPEDECTOMY PROSTHESIS GRANULOMA. ON THE DAY OF THE EVENT DOCTOR PLACED PRODUCT A ROBINSON STAPES PROSTHESIS, PRODUCT NUMBER 1133003, LOT NUMBER 19234200, INTO THE PT FOLLOWING STAPEDECTOMY ON THE RIGHT. ON THE OPERATING TABLE, THE PT WAS ABLE TO HEAR THE DOCTOR WHISPER INTO THE RIGHT EAR. THE DOCTOR SAW THE PT ELEVEN DAYS LATER AT WHICH TIME THE DOCTOR DENOTED A DELAYED PARTIAL FACIAL WEAKNESS. THE DOCTOR PRESCRIBED A PREDNISONE Z-PAK AND ACYCLOVIR. THE DOCTOR SPOKE WITH THE PT IN 2/2002 AND PT INDICATED THAT PT'S FACIAL PARALYSIS WAS RESOLVING. WHEN THE DOCTOR SAW PT AGAIN ALMOST TWO WEEKS LATER, THE TYMPANIC MEMBRANE WAS THICKENED, AND THE MIDDLE EAR APPEARED TO BE FULL OF MATERIAL. A MYRINGOTOMY DISCLOSED POLYPOID MUCOSAL THICKENING AND AUDIOMETRIC EXAMINATION INDICATED NO USEFUL HEARING IN THE RIGHT EAR. DOCTOR PRESCRIBED PREDNISONE AND PAPAVENINE. THE PT DEVELOPED VERTIGO IN MARCH WHICH RESOLVED SPONTANEOUSLY, AND WAS TREATED WITH CIPRO FOR AN EXTENDED PERIOD OF TIME. A CT SCAN DISCLOSED CLOUDED AIR CELLS SPORADICALLY THROUGHOUT THE MASTOID AND THE MIDDLE EAR AND THE EPITYMPANUM WAS OPAQUE. FOUR MONTHS LATER, DOCTOR PERFORMED A MASTOIDECTOMY AND FOUND REACTIVE GRANULATION TISSUE FILLING THE EPITYMPANUM AND THE MIDDLE EAR SPACE. ON FROZEN SECTION THIS TISSUE IDENTIFIED AS REACTIVE GRANULATION TISSUE. THE DOCTOR WAS UNABLE TO SEE THE PROSTHESIS IN THE MIDDLE EAR SPACE BECAUSE THE ENTIRE MIDDLE EAR WAS FILLED WITH GRANULATION TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBINSON STAPES PROSTHESIS 0.6 X 4.0MM W/1MM MIDDLE EAR PROSTHESIS ETB MEDTRONIC XOMED, INC. 1133003 19234200

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Disability SEE B5.