FDA Adverse Event Malfunction Summary report: N

COCHLEAR IMPLANT PROCESSOR BTE

MDR report key: 6806784 · Received August 21, 2017

Report

Report Number
MW5071698
Event Type
Malfunction
Date Received
August 21, 2017
Date of Event
August 17, 2017
Report Date
August 17, 2017
Manufacturer
COCHLEAR AMERICA
Product Code
LXB
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

REPEATEDLY GIVEN DEFECTED COCHLEAR PROCESSORS. I JUST HAD AN IMPLANT SURGERY ON (B)(6) 2017. NEW PROCESSORS GIVEN AND ACTIVATED ON (B)(6) 2017. HERE FOUR MONTHS LATER, I'M GETTING "REFURBISHED" PROCESSORS AND NOT A NEW ONE. BASICALLY, I GOT SERVICE FOR ONLY 4 MONTHS FROM NEW ONE. NOW I'M ONLY RECEIVING "REFURBISHED" PROCESSORS. THAT'S NOT RIGHT, COCHLEAR SHOULD REPLACE WITH ANOTHER NEW ONE. ON TOP OF THAT THE "REFURBISHED" PROCESSOR NOT WORKING PROPERLY NOT EVEN 24 HOURS. SEE COPY OF MY EMAIL TO THEM MIND YOU I'M UP IN THE MIDDLE OF THE NIGHT WRITING THIS AS I AM. VERY STRESSED OUT DUE TO THESE PROBLEMS AND ISSUES. EMAIL TO COCHLEAR. THIS REFURBISHED PROCESSOR WORKED ALL BUT A FEW HOURS. THE RIGHT ONE: 7648465A. DOZED OFF AND JUST WOKE UP AND THIS PROCESSOR "DO NOT WORK ALREADY." IT HAS AN ORANGE/RED DOT ON IT. PERHAPS IT WAS NOT REFURBISHED. THIS HAS GONE PASSED RIDICULOUS. SEND ME ANOTHER ASAP. "WHAT DO I HAVE TO DO." "SUE TO GET A WORKING PROCESSOR!" TRY SENDING ME A NEW THAT I CAN GET MORE THAN 4+ MONTHS SERVICEABLE PERFORMANCE. FDA HAS RECORDS OF PRIOR COMPLAINTS ON THIS PRODUCT. YET COCHLEAR CONTINUE OPERATING AT STATUS QUO. REGARDS, AN IRATE AND DISSATISFIED CUSTOMER. (B)(6). DATE OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: DEAFNESS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
587309 COCHLEAR IMPLANT PROCESSOR BTE COCHLEAR IMPLANT PROCESSOR BTE LXB COCHLEAR AMERICA
587310 COCHLEAR IMPLANT PROCESSOR BTE COCHLEAR IMPLANT PROCESSOR BTE LXB COCHLEAR AMERICA

Patients

Seq Age Sex Outcome Treatment
1 62 YR Other