MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA IMPLANT COCHLEAR IMPLANT

Model Number CI-1600-04

Device Problem Output below Specifications (3004)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/09/2020

Event Type  Malfunction  

Event Description

The recipient is reportedly experiencing decreased performance. Programming adjustments were made and the issue improved, however, the recipient will proceed with revision. Revision surgery will be scheduled.

• Brand Name: HIRES ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: brooke lopez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 10806139
• MDR Text Key: 216836768
• Report Number: 3006556115-2020-01268
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/07/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 05/31/2020
• Device MODEL Number: CI-1600-04
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial