MAUDE Adverse Event Report: COCHLEAR AMERICA COCHLEAR IMPLANT PROCESSOR BTE

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: COCHLEAR IMPLANT PROCESSOR BTE
• Type of Device: COCHLEAR IMPLANT PROCESSOR BTE
• Manufacturer (Section D): COCHLEAR AMERICA
• MDR Report Key: 6806784
• MDR Text Key: 83367918
• Report Number: MW5071698
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 94