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

Model Number CP1000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Edema (1820)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on february 26, 2020.

Event Description

Per the clinic, it was reported that the patient developed an edema at the implant site under the processor coil.Subsequently, the patient was treated with a course of antibiotics (date and duration not reported).The symptoms have reportedly since resolved following treatment.

• Brand Name: CP1000 PROCESSING UNIT BULK, BLACK, PLATINUM DETAIL
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): 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: 9753634
• MDR Text Key: 189706634
• Report Number: 6000034-2020-00508
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Device Catalogue Number: P732093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention