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

Model Number	CI-1500-02H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The recipient reportedly experienced decreased performance and open circuits.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed cuts in the bottom cover overmold and along the electrode.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the electrode ground ring.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The photographic imaging inspection revealed broken wires near the electrode ground ring.It is believed that these breaks caused the open circuits reported.A corrective action was implemented.This version of the hires 90k 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.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 11363190
• Report Number: 3006556115-2021-00130
• Device Sequence Number: 3382489
• Product Code: MCM
• UDI-Device Identifier: 07630016815812
• UDI-Public: (01)07630016815812(11)170424(17)190331
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: CI-1500-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 06/11/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR