77ETD- MEDTRONIC XOMED, INC.

THE MEDTRONIC SALES REP REPORTED FOR THE DOCTOR THAT THE PT DEVELOPED BILATERAL INFLAMMATION AND SWELLING IN BOTH EARS CENTERED IN AREA ON THE TYMPANIC MEMBRANE ADJACENT TO THE VENT TUBES. THE DOCTOR STATED THAT THE TUBES WERE PLACED ON FEB 1ST AND WERE REMOVED FROM THE PT ON (B) (6) 2010. PT WAS PLACED ON CIPRO OTIC AFTER INITIAL PLACEMENT OF THE TUBES. WITHIN 24 HOURS OF PLACING THE TUBES, THE PT DEVELOPED SEVERE PAIN IN THE LEFT EAR AND LESS PAIN IN THE RIGHT EAR. DOCTOR INITIALLY CHANGED HER DROPS TO OFLOXACIN AND THEN STOPPED THE DROPS WHEN THE PAIN CONTINUED. BY POST-OP DAY #3, THE PT HAD DEVELOPED A BILATERAL BULLOUS MYRINGITIS IN THE LEFT EAR MORE SO THAN IN THE RIGHT EAR. THE DOCTOR ELECTED TO REMOVE HER TUBES. AFTER REMOVING THE TUBES, CIPRO OTIC DROPS WERE CONTINUED. THE PT'S PAIN HAS SINCE RESOLVED AND PT HAS RETURNED TO WORK.

NO ANALYSIS OF THE PRODUCT CAN BE PERFORMED AS THE EXPLANTED TUBES WERE SENT BY THE PHYSICIAN FOR CULTURE. THE DOCTOR REPORTED THAT THE PT IS NOW WITHOUT PAIN AND HAS RETURNED TO WORK, HER RIGHT TYMPANIC MEMBRANE HAS HEALED AND IS NO LONGER ERYTHEMATOUS, BUT HER EFFUSION HAS RETURNED ON THE RIGHT EAR. THE MYRINGOTOMY SITE ON THE LEFT SIDE VENT TUBE REMAINS OPEN, BUT THE LEFT TYMPANIC MEMBRANE SHOWS NO INFLAMMATION SINCE THE REMOVAL OF THE VENT TUBE. THE PHYSICIAN STATED THAT THE PT SKIN IS SENSITIVE TO ALL JEWELRY SO SHE DOES NOT WEAR ANY. SINCE SHE HAD NOT BEEN TOLD SPECIFICALLY THAT SHE WAS ALLERGIC TO JEWELRY, SHE HAD NOT REPORTED IT AS AN ALLERGY. THE PT ISSUES RESOLVED WHEN THE PHYSICIAN REMOVED THE TUBES. MEDTRONIC (B) (4) INSTRUCTIONS FOR USE STATEMENTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING SIDE EFFECTS. THE MIDDLE EAR MAY DEVELOP SUBSEQUENT SECONDARY INFECTIONS FROM EITHER WATER OR AIRBORNE PATHOGENS. (CARE SHOULD BE TAKEN TO AVOID WATER ENTERING THE EAR). GRANULOMATOSIS REACTION OF THE TYMPANUM NECESSITATING TUBE REMOVAL. ALLERGIC REACTION MAY OCCUR IN PTS WITH METALS SENSITIVITY. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. THERE IS NO REMAINING INVENTORY OF THE FINISHED GOOD LOT AT MEDTRONIC (B) (4), AND WE HAVE NOT RECEIVED ANY SIMILAR REPORTS. WE ARE FILING THIS REPORT BECAUSE INTERVENTION WAS NECESSARY TO REMOVE THE TUBES.