MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM; PGQ

Model Number CI24RE (L24)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

This report is submitted by cochlear limited on behalf of (b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced pain over the ear and dizziness, however the issue did not resolve.Subsequently the patient was treated with antibiotics (type and date not reported).

Manufacturer Narrative

(b)(4).Correction: per the clinic, the patient experienced a middle ear infection and was treated with antibiotics.Implanted device remains.

• Brand Name: NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM
• Type of Device: PGQ
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial; co 80111 CO 80111
• Manufacturer Contact: pavana nayak ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5978995
• MDR Text Key: 55667170
• Report Number: 6000034-2016-01874
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)141027(17)161027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (L24)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/21/2016
• Device Age: 2 YR
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention