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

Model Number CI-1601-05

Device Problems High impedance (1291); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  Injury  

Event Description

The recipient is reportedly experiencing sound quality issues and increased impedances.The recipient was prescribed steroids in (b)(6) 2019.The recipient's sound quality improved.However, on (b)(6) 2020, the recipient returned with similar symptoms and the clinic prescribed steroids again.The recipient was treated with a second cortison therapy since the first was successful.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's treatment went well.The recipient has resumed device use without further issues.This is the final report.

• Brand Name: HIRES¿ ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9661551
• MDR Text Key: 177535081
• Report Number: 3006556115-2020-00039
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016870262
• UDI-Public: (01)07630016870262(11)190312(17)220331
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR