MAUDE Adverse Event Report: ADVANCED BIONICS, LLC CLARION IMPLANT; COCHLEAR IMPLANT

Model Number AB-5100L

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problem Tinnitus (2103)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The recipient is reportedly experiencing tinnitus.The doctor believes the tinnitus to be device related.The recipient was given medical treatment, however, the issue did not resolve.

Manufacturer Narrative

Advanced bionics no longer considers this event reportable.The recipient has not received any medical intervention for the tinnitus.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient reportedly did not receive medical treatment for the tinnitus.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: CLARION IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10573935
• MDR Text Key: 208142727
• Report Number: 3006556115-2020-01081
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/21/1999
• Device Model Number: AB-5100L
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention