MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

Device analysis report attached.This report is submitted on march 29, 2024.

Event Description

Per the clinic, the patient experienced an episode of meningitis in (b)(6) 2022 and a recurrent episode of meningitis three weeks later (specific dates not reported).The device was explanted on (b)(6) 2023 and it is unknown if there are plans to re-implant the patient as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient was hospitalized (date not reported).The following additional information was received regarding the episodes of meningitis: the patient is reported to have an etiology of congenital hearing loss with cochlear malformation widened iac with csf connection.It is unknown if there were craniofacial malformations.There were no basilar skull fractures.The patient did not receive pre-implant immunizations.Perioperative antibiotics were administered (type and administration not reported) the receiver stimulator was not drilled to the dura, and surgical complications were reported.A csf leak occurred post operatively.The meningitis episodes did not occur within 30 days of a neurologic procedure no vp shunts or lumbar drains were utilized at the onset of meningitis.Prior to meningitis, there were signs of inflammation, fluid in the inner ear, middle ear or mastoid cavity.The patient did have a prior upper respiratory infection or otitis media prior to meningitis.The patients csf cultures revealed gram positive cocci, after the 3rd episode.This report is submitted on may 15, 2024.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19001526
• MDR Text Key: 338877884
• Report Number: 6000034-2024-01093
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)211028(17)231027
• 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,Followup
• Report Date: 04/19/2024

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 Expiration Date: 10/27/2023
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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; Hospitalization; Life Threatening
• Patient Sex: Female