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

Model Number ABI541

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Initial implantation details unavailable at the time of this report.Device not returned to manufacturer.

Event Description

Per the clinic, the patient's device was explanted (date not reported) due to migration of the electrode array.The patient was re-implanted with a new device during the same surgery.

• Brand Name: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
• Type of Device: MHE
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6015946
• MDR Text Key: 56913727
• Report Number: 6000034-2016-01974
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)150804(17)170804
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ABI541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2016
• 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