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

Model Number CI-1600-04

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  malfunction  

Event Description

The recipient reportedly experienced decreased performance.A review of the recipient¿s test data indicated impedance issues and open circuits.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed cuts in the silastic overmold on the top cover.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed an electrode was broken within the electrode pocket.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra device is no longer distributed.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

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 12104826
• MDR Text Key: 262031320
• Report Number: 3006556115-2021-00863
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170215(17)200229
• 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: 06/03/2021

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: 02/29/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2021; 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR