ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A COCHLEAR IMPLANT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL WEEKS FOLLOWING THE PROCEDURE, IT WAS THOUGHT THAT THE PATIENT DEVELOPED AN INFECTION. THE COCHLEAR IMPLANT WAS REMOVED ON (B)(6) 2012. DURING THE PROCEDURE IT WAS NOTED THAT IT WAS AN ALLERGIC REACTION AND NOT AN INFECTION. THE SURGEON OPINES THAT THE ALLERGIC REACTION IS EITHER DUE TO THE COCHLEAR IMPLANT OR THE SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2012-02571 AND MEDWATCH 2210968-2012-02572. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.