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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE(CA)
Device Problems Magnet (482); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Patient Problem Unspecified Infection (1930)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on june 25, 2020.

 
Event Description

Per the clinic, the patient experienced a magnet dislocation during an mri (tesla unknown). The patient's head was not wrapped as recommended by cochlear. The patient then developed an extrusion of the receiver/stimulator body and infection at the implant site that was treated with oral antibiotics. During the explant/re-implantation on (b)(6) 2020, there was a skin revision.

 
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Brand NameNUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS 2109
Manufacturer Contact
bianca pries
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key10193263
MDR Text Key196671961
Report Number6000034-2020-01538
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberCI24RE(CA)
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/25/2020 Patient Sequence Number: 1
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