FDA Adverse Event Other Summary report: N

MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

MDR report key: 1188332 · Received October 7, 2008

Report

Report Number: 9710014-2008-00322
Event Type: Other
Date Received: October 7, 2008
Report Date: September 26, 2008
Manufacturer: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
Product Code: MCM
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SURGEON CALLED MED-EL CORP AND REPORTED THAT THE PATIENT DEVELOPED A WOUND INFECTION 6-8 WEEKS AFTER HIS RE-IMPLANTATION ON (B) (6), 2008. THE PATIENT CONTINUES TO SWIM IN THE LAKE DESPITE THE SURGEON'S SUGGESTION THAT HE SHOULD NOT. IMMEDIATELY ADJACENT TO THE WOUND IS THE ELECTRODE. THE PATIENT'S MOM CALLED THE SURGEON 2 DAYS AGO AND REPORTED THAT THE ELECTRODE COULD BE SEEN WITH THE HUMAN EYE. THE SURGEON ALSO MENTIONED THAT HE USES BONE WAX VERY INFREQUENTLY AND SPARINGLY WHEN HE DOES. HE HAS FOUND A VERY SMALL PIECE OF BONE WAX BEING PUSHED OUT OF THE PATIENT'S INCISION SINCE RE-IMPLANTATION. THE CURRENT PLAN IS TO EXPLANT THE DEVICE, CLEAN THE CAVITY, AND RE-IMPLANT. IF THIS DOES NOT WORK THEN THEY WILL EXPLANT, CLEAN OUT EVERYTHING, CLOSE UP, AND LET THINGS CALM DOWN BEFORE RE-IMPLANTING. THEY ARE NOT GOING THE SECOND ROUTE FIRST AS THE PATIENT IS BILATERALLY IMPLANTED AND THROWS A FIT WHEN HE DOESN'T HAVE BOTH SIDES ON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	COCHLEAR IMPLANT	MCM	MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH	SONATA

Patients

Seq	Age	Sex	Outcome	Treatment
1	5 YR