MAUDE Adverse Event Report: COCHLEAR LIMITED CP1000 MAGNET (3 (I), BLACK) - SINGLE PACKED; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Ulcer (2274); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Per the clinic, the patient had developed open sores at the magnet site and subsequently, a lower strength magnet exchange resolved the issue.

Manufacturer Narrative

This report is submitted on october 05, 2022.

Manufacturer Narrative

Correction: the previous or initial mdr submitted on october,05 was filed inadvertently.The development of a sore at the magnet site is not reportable, no serious injury has occurred.This report is submitted on november 19, 2022.

• Brand Name: CP1000 MAGNET (3 (I), BLACK) - SINGLE PACKED
• 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: belinder gill ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15541479
• MDR Text Key: 301151443
• Report Number: 6000034-2022-02991
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

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: P1473283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 12/19/2022
• 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 Sex: Male