MAUDE Adverse Event Report: COCHLEAR LIMITED CP1150 MAGNET (STRENGTH 4(I)); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1150

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Erosion (2075); Tissue Breakdown (2681); Skin Infection (4544)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 9, 2022.

Event Description

Per the clinic, the patient experienced skin irritation at the magnet site resulting in an infection with was successfully treated with oral and topical antibiotics.The implant remains in-situ.

Manufacturer Narrative

Per the clinic, the patient experienced skin and tissue breakdown due to the pressure at the magnet site.This report is submitted on december 16, 2022.

• Brand Name: CP1150 MAGNET (STRENGTH 4(I))
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: yaneesa vetsandonphong ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15947310
• MDR Text Key: 305134795
• Report Number: 6000034-2022-03710
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)220428(17)240427
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2024
• Device Model Number: CP1150
• Device Catalogue Number: P1540175
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male