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

Model Number CI-1601-05

Device Problem Defective Device (2588)

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

Event Date 06/20/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing open electrodes.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top and bottom covers, and the electrode was sliced along the lead prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires at the fantail.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The scanning electron microscopy analysis confirmed tensile breaks at some electrode wires within the fantail.The photographic imaging inspection and scanning electron microscopy analysis revealed broken wires in the fantail region.It is believed that these breaks caused the open impedances recorded.Advanced bionics will continue to monitor for failure modes of this type and will implement corrective actions as necessary.This is the final report.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 reportedly explanted.The recipient was reimplanted with another advanced bionics device.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: 8687265
• MDR Text Key: 147705971
• Report Number: 3006556115-2019-00299
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190206(17)220131
• 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,Followup,Followup
• Report Date: 05/21/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/15/2019; 10/07/2019; 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR