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

Model Number ABI541

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the recipient was hospitalized for an revision surgery to repair a csf leak post operatively.The implanted device remains.Per the clinic, the recipient is recovering well.

Manufacturer Narrative

Correction: the date of this report is 05 august 2019; not 21 august 2019 as previously reported.This report is submitted on 19 november 2019.

• 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, 2109 ; AS 2109
• MDR Report Key: 9206159
• MDR Text Key: 162801049
• Report Number: 6000034-2019-02194
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• PMA/PMN Number: P000015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2019,10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ABI541
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Distributor Facility Aware Date: 08/21/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention