ESTEEM

MDR report key: 7114537 · Received December 13, 2017

Report

Report Number: 3004007782-2017-00010
Event Type: Injury
Date Received: December 13, 2017
Date of Event: July 11, 2017
Report Date: August 9, 2017
Manufacturer: ENVOY MEDICAL CORP.
Product Code: OAF
PMA / PMN Number: P090018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE PASSED ALL MANUFACTURING ACCEPTANCE TESTING AND QUALITY INSPECTION.

Description of Event or Problem · 1

PATIENTS WIFE CALLED LATE ON (B)(6) 2017. ESTEEM HAS STOPPED WORKING AND THE BATTERY IS SUSPECTED TO BE DEAD OR SOMETHING MALFUNCTIONED WITH IT. BATTERY WAS CHANGED IN 2015. A COUPLE OF MONTHS AGO IT STARTED CUTTING IN AND OUT AND DISTORTING, A FEW DAYS AGO IT STOPPED WORKING. PATIENT HISTORY: (B)(6) 2010 - INITIAL IMPLANT, (B)(6) 2011 - ACTIVATION AND FITTING, (B)(6) 2014 - PATIENT FITTING, (B)(6) 2015 - BATTERY REPLACEMENT, (B)(6) 2017 - CASE REVIEW IN RESPONSE TO COMPLAINT, (B)(6) 2017 - REVISION SURGERY. DURING REVISION SURGERY, DRIVER AND SENSOR TESTED "GOOD". SOUND PROCESSOR (BATTERY) WAS REPLACED AS A NORMAL PRECAUTIONARY PROCEDURE. ON 08/04/2017 - SP WAS RECEIVED AT ENVOY MEDICAL, (B)(6) 2017 - SP WAS TESTED AND DEVICE INITIALLY FAILED FUNCTIONAL TESTING. ON (B)(6) 2017 - SP WAS TESTED INDEPENDENTLY FOR THE ABILITY TO PROCESS AUDIO INPUT SIGNALS AND DEVICE WAS FOUND TO BE FUNCTIONING AS EXPECTED. FULL FUNCTIONAL TESTING (FFT) WAS REPEATED AND DEVICE NOW PASSES FFT. FAILURE TO PASS FFT ON (B)(6) 2017 MAY HAVE BEEN DUE TO TEST SETUP. TEST FAILURE COULD NOT BE REPRODUCED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
892465	ESTEEM	ESTEEM II SOUND PROCESSOR	OAF	ENVOY MEDICAL CORP.	2001	EMC0005473

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention