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U.S. Department of Health and Human Services

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

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COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
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.
 
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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 Key7140668
MDR Text Key95581003
Report Number6000034-2017-02287
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502009317
UDI-Public(01)09321502009317(11)170117(17)190116
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P970051
Number of Events Reported1
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 Date01/16/2011
Device Model NumberCI24RE (ST)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2017
Initial Date FDA Received12/21/2017
Supplement Dates Manufacturer Received12/29/2017
Supplement Dates FDA Received01/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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