MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K IMPLANT COCHLEAR IMPLANT

Model Number CI-1400-01

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  Malfunction  

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. It is believed that the recipient experienced an in-situ failure. A review of the device history record was completed and no anomalies were noted. The recipient remains implanted. This is the final report.

Event Description

The recipient is reportedly experiencing impedance issues and potential device failure. Device testing results revealed abnormal results. External equipment was exchanged, however, the issue did not resolve. The recipient will not be explanted at this time.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 10691325
• MDR Text Key: 213487679
• Report Number: 3006556115-2020-01117
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (Y/N): N
• Reporter Country Code: DE
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/23/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/16/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 06/01/2005
• Device MODEL Number: CI-1400-01
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/27/2003
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial