FDA Adverse Event Malfunction Summary report: N

MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

MDR report key: 905916 · Received August 31, 2007

Report

Report Number: 9710014-2007-00234
Event Type: Malfunction
Date Received: August 31, 2007
Date of Event: August 26, 2007
Report Date: August 31, 2007
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 FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S AUDIOLOGIST CONTACTED MED-EL CORP STATING THAT THE PATIENT'S IMPLANT HAD STOPPED WORKING 2007. THE PATIENT ATTENDED THE CLINIC THREE DAYS LATER, AND HER MOTHER REPORTED THA,T THE PATIENT COULD NO LONGER HEAR WITH HER IMPLANT. THE AUDIOLOGIST CHECKED THE IMPEDANCES AND FOUND THAT THE GROUND ELECTRODE SHOWED A DASHED LINE AND ALL OF THE ELECTRODES SHOWED HIGH IMPEDANCE. THE AUDIOLOGIST SAID THAT PRIOR TO THIS EVENT ALL HER IMPEDANCES HAD BEEN VERY STABLE. THE MOTHER DID NOT REPORT ANY HITS/BUMPS TO THE HEAD OR ANY FALLS. THE PATIENT, HOWEVER, DOES HAVE SIGNIFICANT BALANCE ISSUES DUE TO A MALFORMED VESTIBULAR SYSTEM. SHE CURRENTLY USES A WALKER OR A WHEELCHAIR TO GET AROUND.

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	PULSAR

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR