MAUDE Adverse Event Report: COCHLEAR LTD CP1000 MAGNET (2 M, BROWN); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Disorders (4543)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 03,2022.

Event Description

Per the clinic, the patient underwent a skin flap revision surgery under general anesthesia on (b)(6) 2022 to remove the affected tissue.The implanted device remains.

• Brand Name: CP1000 MAGNET (2 M, BROWN)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 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: belinder gill ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13657404
• MDR Text Key: 286486758
• Report Number: 6000034-2022-00568
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Device Catalogue Number: Z586149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/02/2022
• 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
• Patient Age: 12 YR
• Patient Sex: Male