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

Model Number CI-1500-04

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Skin Discoloration (2074)

Event Type  Injury  

Event Description

The recipient is reportedly experiencing irritation at the implant site due to the headpiece.The recipient is presenting with a callous, soreness, and skin discoloration.The recipient's nurses used bactroban mupirocin, which was not prescribed for the irritation, 1-2 times per day for 2-3 weeks.The recipient was recommended to cease device use and follow-up with a physician.The recipient's implant site is healing.

Manufacturer Narrative

The recipient's magnet strength was reportedly lowered and moleskin was applied.The recipient's soreness and scabbing has healed.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly had an in office surgery on (b)(6) 2019.The recipient's incision revealed a lesion of seborrheic keratosis along long axis post auricular sulcus.On (b)(6) 2019, a small hematoma was noted.The recipient was recommended bacitracin for 7 days.Additional information regarding treatment details were not provided.The recipient's issues resolved.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE 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: 8476076
• MDR Text Key: 140731300
• Report Number: 3006556115-2019-00149
• Device Sequence Number: 0
• Product Code: MCM
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2017
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• 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