MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

Additional information was requested regarding patient treatment details; however, could not be made available as of the date of this report.Should more information be provided, a supplimentary report shall be submitted.This report is submitted december 22, 2017.

Event Description

Per the clinic, it was reported that the patient developed a fever post-operatively, for a duration of one month.The patient was subsequently diagnosed with meningitis and was hospitalized and treated with antibiotics (date, type and duration not reported).The meningitis episode reportedly resolved, and the device was explanted (date not reported).

Manufacturer Narrative

The following additional information was received regarding the episode of meningitis: -etiology of deafness - the patient has an etiology of mondini malformation (ip2).-there is no reported craniofacial malformations.-there was no previous history of meningitis, it is unknown if there were any csf leaks.-the patient did not receive pre-implant immunization.-no perioperative antibiotics were administered.-the receiver-stimulator well was drilled into dura.- it is unknown if the meningitis episode occurred within 30 days of a neurologic procedure or if vp shunts or lumbar drains were utilized at the onset of meningitis.- it is unknown if prior to meningitis, the patient experienced any upper respiratory infection or otitis media.- no organism was cultured.The patient was hospitalized for two weeks and antibiotic treatment was successful.Explant occurred on (b)(6) 2017.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7140668
• MDR Text Key: 95581003
• Report Number: 6000034-2017-02287
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502009317
• UDI-Public: (01)09321502009317(11)170117(17)190116
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

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: 01/16/2011
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/29/2017
• Supplement Dates FDA Received: 01/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• 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