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

Model Number ABI541

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 18 2019.

Event Description

Per the clinic, the patient was explanted on (b)(6) 2019 because of a suspected device failure.The patient was re-implanted with a device at the same surgery.

Manufacturer Narrative

Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2019-01049.This report is submitted on 6 march 2020.

• Brand Name: NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
• Type of Device: NUCLEUS AUDITORY BRAINSTEM 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 Key: 8706509
• MDR Text Key: 148416282
• Report Number: 6000034-2017-01049
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)110520(17)130519
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2013
• Device Model Number: ABI541
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2011
• 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