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

Model Number CI-1500-01

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 10/20/2019

Event Type  Injury  

Event Description

The recipient is reportedly experiencing headpiece retention issues.The recipient underwent skin flap surgery on (b)(6) 2019.

Manufacturer Narrative

The recipient is still experiencing retention issues.Surgery to revise the magnet will be scheduled.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 recipient's will reportedly not undergo surgery at this time.The recipient continues to use the device with a headband.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: 9865990
• MDR Text Key: 184483868
• Report Number: 3006556115-2020-00202
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016861741
• UDI-Public: (01)07630016861741(11)180910(17)200831
• 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
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR