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

Model Number CI-1600-04

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2020

Event Type  Malfunction  

Event Description

Advanced bionics was informed that device testing revealed abnormal results. Programming adjustments were made, however, the issue did not resolve. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

• 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: 10645700
• MDR Text Key: 211437118
• Report Number: 3006556115-2020-01118
• 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,HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/07/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 08/31/2020
• Device MODEL Number: CI-1600-04
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 09/07/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial