MAUDE Adverse Event Report: COCHLEAR LTD CP1150 SOUND PROCESSOR (SLATE GREY); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1150

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Discomfort (2330)

Event Date 04/17/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced discomfort and headache with external device use.Subsequently, the patient was administered with oral antibiotics on (b)(6) 2023 (duration not reported).

• Brand Name: CP1150 SOUND PROCESSOR (SLATE GREY)
• 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: 16944496
• MDR Text Key: 315352054
• Report Number: 6000034-2023-01537
• 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
• Type of Report: Initial
• Report Date: 05/17/2023,04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1150
• Device Catalogue Number: P1320277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Distributor Facility Aware Date: 04/26/2023
• Date Report to Manufacturer: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR