MAUDE Adverse Event Report: COCHLEAR LIMITED CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (BROWN); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on july 18, 2023.

Event Description

Per the clinic, the rechargeable battery was found to have allegedly leaked fluid.Replacement equipment was sent.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Correction: the correct medical device problem code is 1354; not 1250 as previously reported.This report is submitted on november 24, 2023.

• Brand Name: CP1000 STANDARD RECHARGEABLE BATTERY MODULE PACKED (BROWN)
• 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17339929
• MDR Text Key: 319332433
• Report Number: 6000034-2023-02399
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Device Catalogue Number: Z544551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2023
• 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): Other
• Patient Sex: Male