MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number ABI541

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Impairment (1881); Pain (1994)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted august 14, 2018.

Event Description

Per the clinic, the patient experienced pain and a performance decrement with subsequent loss of connection to the internal device; resulting in the decision to explant the device on (b)(6) 2018.The patient was reimplanted with a new device during the same surgery.

• Brand Name: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7780582
• MDR Text Key: 117033233
• Report Number: 6000034-2018-01654
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)160504(17)180503
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2018
• Device Model Number: ABI541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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
• Patient Age: 24 YR