MAUDE Adverse Event Report: COCHLEAR LTD CP910 PROCESSING UNIT (SMOKE); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900

Device Problem Biocompatibility (2886)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 11, 2019.

Event Description

Per the clinic, the patient developed skin irritation at the implant site and was subsequently treated with an antibiotic (type not reported).

• Brand Name: CP910 PROCESSING UNIT (SMOKE)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8986534
• MDR Text Key: 157327600
• Report Number: 6000034-2019-01723
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900
• Device Catalogue Number: Z285968
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• 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