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

Model Number CI-1500-04

Device Problems Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Intermittent Communication Failure (4038)

Patient Problems Head Injury (1879); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The recipient is reportedly experiencing intermittency and loss of sound following a head trauma incident.External equipment was exchanged.Lock was achieved during device testing.Programming adjustments were made; however, the issue did not resolve.Revision surgery is under consideration.

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

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed dislodged electrical components within the hybrid.System lock was lost while manipulating the hybrid case.The electrode condition prevented an electrical test from being performed.The scanning electron microscopy (sem) analysis of the electrode revealed damage was a result of slicing.This is believed to have occurred during revision surgery.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The reported complaint of open electrodes could not be verified during this analysis, which was limited in some respects due to the electrode being damaged prior to receipt.However, this device was received with dislodged electrical components, which is consistent with the trauma reported.This older device configuration is not currently manufactured.A corrective action was implemented.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

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed.This is believed to have occurred during revision surgery.In addition, this inspection revealed a dented bottom cover.The photographic imaging inspection revealed dislodged electrical components within the hybrid.System lock was lost while manipulating the hybrid case.The electrode condition prevented an electrical test from being performed.The scanning electron microscopy (sem) analysis of the electrode revealed damage was a result of slicing.This is believed to have occurred during revision surgery.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The reported complaint of open electrodes could not be verified during this analysis, which was limited in some respects due to the electrode being damaged prior to receipt.However, this device was received with dislodged electrical components, which is consistent with the trauma reported.This older device configuration is not currently manufactured.A corrective action was 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: heidi white ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 17652993
• MDR Text Key: 322315353
• Report Number: 3006556115-2023-01469
• Device Sequence Number: 1
• Product Code: MCM
• 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,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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: 78 YR
• Patient Sex: Female