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

Model Number CI-1500-01

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Intermittent Communication Failure (4038)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/26/2021

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing loss of lock.External equipment was exchanged, however, the issue did not resolve.A ct scan revealed results within normal limits.Revision surgery will be scheduled.

Manufacturer Narrative

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed sliced silicone on the top cover.This is believed to have occurred during revision surgery.In addition, a dented bottom cover was observed.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.The internal visual inspection revealed that the bond wires on the digital chip were shorted together.The failure of this device is attributed to multiple shorted wirebonds at the digital chip, which prevented the device from achieving lock in-situ.An internal corrective action has been implemented.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
• 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: 12072209
• MDR Text Key: 261494090
• Report Number: 3006556115-2021-00960
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016861741
• UDI-Public: (01)07630016861741(11)200319(17)220228
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2021

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: 02/28/2022
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2021; 12/08/2021; 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male