MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ 3D ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-04

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Undesired Nerve Stimulation (1980); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2022

Event Type  Injury  

Event Description

The recipient is reportedly experiencing extrusion and facial nerve stimulation.The surgeon states the recipient has a malformed cochlea.A ct scan found that the electrode is sitting in the internal auditory canal (iac) due to the recipient's anatomy (thinning structure, enlarged iac opening).Revision surgery is scheduled.

Manufacturer Narrative

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

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 that the electrode array was severed.Slices in the silicone were also observed on the top and bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode prevented an electrical test from being performed.The device passed the electrical and mechanical test performed.This device was explanted for medical reasons.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¿ 3D ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: vanessa lerma ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 15066276
• MDR Text Key: 296255751
• Report Number: 3006556115-2022-01174
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016877995
• UDI-Public: (01)07630016877995(11)211112(17)241031
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2022; 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• 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