VIBRANT SOUNDBRIDGE

MDR report key: 5508132 · Received February 22, 2005

Report

Report Number: 3004230826-2005-00015
Event Type: Malfunction
Date Received: February 22, 2005
Date of Event: April 1, 2005
Report Date: February 22, 2005
Manufacturer: SYMPHONIX, INC., C/O VIBRANT MED-EL, HEARING TECHNOLOGY GMBH
Product Code: MPV
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT YET BEEN EXPLANTED.

Description of Event or Problem · 1

THE PATIENT HAS HAD CONTINUING PROBLEMS WITH HIS SOUNDBRIDGE DEVICE. THEIR DEVICE WAS ACTIVATED IN (B)(6) 2002 ON THE RIGHT SIDE. THE CLINIC HAS WORKED WITH THE PATIENT SINCE THEIR ACTIVATION, ADJUSTING AND MAINTAINING THE DEVICE, BUT REPORTEDLY THEY HAVE NEVER BEEN COMPLETELY SATISFIED WITH IT'S BENEFITS. THEY RECENTLY NOTICED THAT THE AP WAS NOT WORKING. IT WAS SENT IN FOR REPAIR BUT UPON IT'S RETURN THEY REPORTED THAT IT WAS STILL NOT FUNCTIONING. IT WAS RECOMMENDED THAT THEY SCHEDULE AN APPOINTMENT TO SEE THEIR AUDIOLOGIST TO DETERMINE WHAT WAS WRONG. THE PATIENT RETURNED TO THEIR CLINIC IN 2005 FOR A FOLLOW-UP APPOINTMENT AND THE AUDIOLOGIST TESTED THE PATIENT'S SEARING AND THERE HAD BEEN A DECREASE BILATERALLY FROM 750 - 2,000 HZ BUT MORE NOTABLY IN THE RIGHT EAR. THE AUDIOLOGIST REPROGRAMMED THE SOUNDBRIDGE, BUT EVEN AT MAXIMUM SETTING THE PATIENT REPORTED NO DIFFERENCE IN SOUND AT ALL WITH THE DEVICE ON, HOWEVER, NO FORMAL FUNCTIONAL GAIN TESTING WAS PERFORMED. A LISTENING CHECK ON THE DEVICE REVEALED THAT IT WAS FUNCTIONING PROPERLY. STARTING LAST WINTER THEY HAD MORE TROUBLE UNDERSTANDING THE CONVERSATION OF OTHERS. CHANGING BATTERIES DID NOT SOLVE THE PROBLEM. FINALLY THE SOUNDBRIDGE STOPPED WORKING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VIBRANT SOUNDBRIDGE	MIDDLE EAR IMPLANT	MPV	SYMPHONIX, INC., C/O VIBRANT MED-EL, HEARING TECHNOLOGY GMBH	VORP

Patients

Seq	Age	Sex	Outcome	Treatment
1