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

Model Number CI-1600-04

Device Problem Product Quality Problem (1506)

Patient Problem Hearing Impairment (1881)

Event Date 07/13/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing decreased performance and sound quality issues.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top cover and the electrode was severed near the fantail and array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical test performed.Advanced electrical testing performed on the device revealed 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.

Manufacturer Narrative

Additional information: section d.7 advanced bionics considers the investigation into this reportable event as closed.The recipient experienced a superficial breakdown of skin along the incision site.There was no abscess or dehiscence of the incision.The recipient was prescribed oral antibiotics and advised to cease device use.The skin breakdown has resolved and the incision site is healthy.The recipient has resumed device use.Additional treatment details will not be provided.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 IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9938965
• MDR Text Key: 187071575
• Report Number: 3006556115-2020-00246
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170404(17)200331
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR