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

Model Number CI-1601-05

Device Problems Mechanical Problem (1384); Impedance Problem (2950); Output below Specifications (3004); Appropriate Term/Code Not Available (3191)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

The recipient reportedly experienced decreased performance and sound quality issues.A review of the recipient¿s test data indicated impedance issues.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the array was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.Advanced electrical testing performed on the device showed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra is no longer distributed.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
• MDR Report Key: 11032884
• MDR Text Key: 222638357
• Report Number: 3006556115-2020-01484
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)180831(17)210831
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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: 08/31/2021
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 MO