MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (L24)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Headache (1880)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced poor device performance and non-auditory sensations from activation.The device was explanted (b)(6) 2019, and the patient was reimplanted with a new device during the same surgery.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 8694368
• MDR Text Key: 147849448
• Report Number: 6000034-2019-00966
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)151014(17)171013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/13/2017
• Device Model Number: CI24RE (L24)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR