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

Model Number CI-1400-01

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 05/13/2020

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing sound quality issues.External equipment was exchanged, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was explanted.The recipient was re-implanted with another advanced bionics cochlear device.The recipient is doing well.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed prior to receipt.In addition, severe surgical tool damage was observed on the top and bottom cover and seam weld.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The scanning electron microscopy analysis revealed a crack on the seam weld which is believed to have been sustained during the revision surgery.The internal visual inspection noted silver migration across some electrical components.The reported complain of overly loud sound could not be verified during this analysis, which was limited in some respects due to the damage the device sustained during the revision surgery.This device had a gross leak failure at the case-band braze, which is believed to have been induce during revision surgery.Due to the state of the device most tests were compromised and pinpointing the root cause was not possible.A corrective action was implemented.Feed thru assemblies from his 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: 10014928
• MDR Text Key: 189834173
• Report Number: 3006556115-2020-00340
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2006
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR