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  Injury  

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
• MDR Report Key: 9753608
• MDR Text Key: 181548317
• Report Number: 6000034-2020-00509
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2020,02/03/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2020
• Distributor Facility Aware Date: 02/03/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention