MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Type  Injury  

Event Description

The recipient reportedly experienced a hematoma followed by a post-auricular wound.The recipient presented with breakdown and draining for 3 weeks.Despite appropriate wound care the implant is now visible.The recipient's device was explanted.The recipient may be reimplanted once the site has healed.

Manufacturer Narrative

The recipient is reportedly in the process of healing.

Event Description

The recipient reportedly experienced a hematoma followed by a post-auricular wound.The recipient presented with breakdown, initial draining of the wound was done at 3 weeks, followed by additional office procedures.Despite appropriate wound care, the implant is now visible.The recipient's device was explanted.The recipient may be reimplanted once the site has healed.

Manufacturer Narrative

The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.

Manufacturer Narrative

The recipient is reportedly healing well, however, an exposed edge of mastoid bowl with sharp bone is protruding through the skin.The doctor removed the sharp bony edge and placed a stitch with prolene.The recipient's wound was treated with an antibiotic ointment.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.The recipient has reportedly healed.This is the final report.

• Brand Name: HIRES¿ ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 8629846
• MDR Text Key: 145843150
• Report Number: 3006556115-2019-00249
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)181206(17)211130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention