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

Model Number CI-1500-01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Head Injury (1879); No Information (3190)

Event Date 07/01/2017

Event Type  Injury  

Event Description

The recipient was reportedly explanted following a head trauma incident.The recipient was not reimplanted at this time.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was explanted due to an abscess.The recipient recovered from explant surgery.Additional information regarding treatment details are not available.The device will not return to the company for analysis.A review of the device history record was completed and no anomalies were noted.This is the final report.

Manufacturer Narrative

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 cuts in the silicone on the top and bottom covers.Also, the electrode was severed prior to receipt.This is 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.This device was explanted for medical reasons.The device passed the electrical tests performed.However, this device had a gross leak at the seam weld.This was induced during the failure analysis process.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 ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8897105
• MDR Text Key: 154429656
• Report Number: 3006556115-2019-00503
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)160812(17)180731
• 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,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/13/2019; 12/29/2020; 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR