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

Model Number CI-1601-05

Device Problem Fracture (1260)

Patient Problem Wound Dehiscence (1154)

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 company was informed that the recipient reportedly developed wound dehiscence, device extrusion, and drainage in (b)(6) 2023.In (b)(6) 2023 she underwent closure of the scalp over the dehiscent device.Several months later, there was a reoccurrence of the dehiscence.On (b)(6) 2024, the recipient's device was explanted.During surgery it was noted that the electrode appeared to be partially extruded with electrode noted in the mastoid cavity.The recipient was not re-implanted.

Manufacturer Narrative

Correction information: section g.3 the original reportable date of awareness has been corrected to march 28, 2024.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES¿ ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: laurel masamitsu ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 19183187
• MDR Text Key: 341060057
• Report Number: 3006556115-2024-00676
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878008
• UDI-Public: (01)07630016878008(11)210610(17)240531
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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 Expiration Date: 05/31/2024
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 Sex: Female