MAUDE Adverse Event Report: COCHLEAR LTD CP1000 PROCESSING UNIT BULK, BLACK; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 06 november 2019.

Event Description

Per the clinic, the patient experienced pain and skin irritation at external processor site, subsequently the patient was hospitalised on three separate occasions for a duration of 2 weeks each time and placed on iv antibiotics.Clinical management is ongoing.

• Brand Name: CP1000 PROCESSING UNIT BULK, BLACK
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 9282581
• MDR Text Key: 165295900
• Report Number: 6000034-2019-02232
• 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
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• 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): Hospitalization; Required Intervention