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

Model Number CI-1601-05

Device Problems Migration or Expulsion of Device (1395); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

The company was informed the recipient will reportedly undergo revision surgery due to electrode migration.

Manufacturer Narrative

Additional information: section d.6b.The recipient reportedly underwent repositioning surgery on november 3, 2021.The recipient is doing well.The recipient remains implanted.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 recipient's adjustment reportedly went well.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 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 12643359
• MDR Text Key: 279349313
• Report Number: 3006556115-2021-01587
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878046
• UDI-Public: (01)07630016878046(11)200213(17)230131
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 09/24/2021

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: 01/31/2023
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2021; 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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: 39 YR
• Patient Sex: Male