MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT

Model Number CI-1400-02H

Device Problems Product Quality Problem (1506); Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

The recipient reportedly experienced a sound quality issue.External equipment was exchanged, however, the issue did not resolve.The recipient ceased device use.On (b)(6) 2019, the recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient is doing well.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed near the fantail, and cut silicone overmold was observed on both top and bottom covers prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across some electrical components.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies from this vendor are no longer used.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 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8689366
• MDR Text Key: 147862846
• Report Number: 3006556115-2019-00330
• Device Sequence Number: 1
• Product Code: MCM
• 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: 05/21/2019

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: 09/01/2007
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR