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  

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).Additional information has been requested but has not been made available as of the date of this report.

Event Description

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.

• 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
• MDR Report Key: 19009808
• MDR Text Key: 338979089
• Report Number: 6000034-2024-01096
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)210607(17)230606
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2024,04/19/2024

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: 06/06/2023
• Device Model Number: CI622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2024
• Distributor Facility Aware Date: 04/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female