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

Model Number CI-1400-01

Device Problem Device Slipped (1584)

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

Event Date 08/20/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issues did not resolve.

Manufacturer Narrative

The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.A review of the device history record was completed and no anomalies were noted.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's device was reportedly discarded and will not return to advanced bionics for analysis.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8998251
• MDR Text Key: 160210018
• Report Number: 3006556115-2019-00558
• 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: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2005
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2019; 02/24/2020; 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR