THE RN REPORTED THAT SHE DID A CASE WITH THE DR ON A LITTLE GIRL THAT HAD AN EAR PROSTHESIS PUT IN LAST YEAR. IN A SURGERY IN 2008, DR FOUND THE PROSTHESIS THAT SHE HAD PUT IN WAS BROKEN IN 2 PIECES. THEY PUT IN A DIFFERENT PROSTHESIS FROM THE BROKEN ONE AND SAVED THE OLD PROSTHESIS. THE RN CAN'T TELL EXACTLY IF THE PT NEEDED THE SECOND SURGERY (2008), BECAUSE THE PROSTHESIS WAS BROKEN AND NOT FUNCTIONING, OR IF IT WAS FOR A FOLLOW-UP/2ND STAGE REPAIR PROCEDURE. THIS HAD NOT BEEN CLARIFIED WITH THE DR. THE NURSE'S UNDERSTANDING FROM THE SURGEON IS THAT WHEN THE PROSTHESIS BECAME EXPOSED, SHE FOUND IT BROKEN IN TWO. SHE DID NOT USE THE SAME PROSTHESIS TO REPLACE THE ONE FIRST IMPLANTED.
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Patient 1
THE PROSTHESIS HAS NOT YET BEEN RETURNED, THEREFORE, AN EVALUATION IS NOT POSSIBLE. DESPITE SEVERAL ATTEMPTS, WE HAVE NOT BEEN ABLE TO CONFIRM WITH THE DR THAT THE PT HAD LOST HEARING PRIOR TO THE SECOND SURGERY, WHICH WOULD CONFIRM THAT THE PROSTHESIS WAS BROKEN BEFORE THE SURGERY. WE ARE SUBMITTING THIS REPORT AS A SERIOUS INJURY BASED ON THE ASSUMPTION THAT THE PT'S HEARING HAD BEEN LOST/IMPAIRED. THIS IS THE FIRST REPORT OF THIS TYPE ON THIS PRODUCT, AND IT IS CONSIDERED TO BE AN ISOLATED OCCURRENCE. THIS REPORT SHOULD NOT BE CONSTRUED AS AN ADMISSION BY MEDTRONIC XOMED DANGEROUS IN ANY RESPECT OR THAT ANY CASUAL RELATIONSHIP EXISTS BETWEEN THE PRODUCT AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY MEDTRONIC XOMED SHOULD NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS, IN FACT, OCCURRED.