MAUDE Adverse Event Report: COCHLEAR LTD CP1000 PROCESSING UNIT BULK, BROWN; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 23, 2021.

Event Description

Per the clinic, the patient experienced recurrent infection and drainage behind the ear due with speech processor use, and subsequently was treated with antibiotics (date and duration not reported).The implanted device remains.

• Brand Name: CP1000 PROCESSING UNIT BULK, BROWN
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: weiting zhen ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11548294
• MDR Text Key: 241699665
• Report Number: 6000034-2021-00878
• Device Sequence Number: 1
• Product Code: MCM
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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