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

Model Number CI-1601-05

Device Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 07/18/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing poor sound quality due to 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 the silicone and electrode were damaged at the fantail prior to receipt.The photographic imaging inspection revealed multiple damaged 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 multiple wires were cut and damaged at the fantail.The photographic imaging inspection and the scanning electron microscopy analysis revealed damaged silicone and electrode wires at the fantail region.It is believed that the damaged wires caused the open impedances measured in the operating room and at the clinic.Advanced bionics will continue to monitor failure modes of this type.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 explanted.The recipient was reimplanted with another advanced bionics cochlear 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: 8875490
• MDR Text Key: 153954330
• Report Number: 3006556115-2019-00500
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190312(17)220228
• 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
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR