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

Model Number CI-1600-05

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problems Bruise/Contusion (1754); Fall (1848); Head Injury (1879); Partial Hearing Loss (4472)

Event Date 08/10/2021

Event Type  Injury  

Event Description

The recipient reportedly experienced no sound after a fall on the implant site and developed a bump and bruising.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics device.

Manufacturer Narrative

The recipient is reportedly doing well.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.Device testing revealed open circuits prior to revision surgery.The external visual inspection revealed cuts to the silastic cover, fantail region, and a severed array.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the fantail.System lock was verified.The device passed the electrical and mechanical tests performed.The photographic imaging inspection revealed broken electrode wires near the fantail.It is believed that these breaks caused the open impedances measured at the clinic.Advanced bionics will continue to monitor failure modes of this type.This version of the hires 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.

• Brand Name: HIRES¿ ULTRA 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: 12408186
• MDR Text Key: 270887881
• Report Number: 3006556115-2021-01221
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016857201
• UDI-Public: (01)07630016857201(11)171020(17)201031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male