MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM

Model Number CI532

Device Problem Missing Value Reason (3192)

Patient Problem Vertigo (2134)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced severe vertigo and was subsequently hospitalized (date and duration not reported).

Manufacturer Narrative

Per the clinic, it was reported that the vertigo experienced by the patient was determined to not be device related.(b)(4).

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial CO 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5881081
• MDR Text Key: 52274288
• Report Number: 6000034-2016-01595
• Device Sequence Number: 1
• Product Code: MCM
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI532
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/24/2016
• Date Manufacturer Received: 08/24/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention