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 Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 14, 2017, by cochlear limited on behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, the patient experienced an episode of meningitis within 30 days of implantation (specific date not reported).The patient was hospitalised for a period of 1 week and treated with an iv antibiotic.The patient has since recovered and the device remains implanted.The following additional information was received regarding the episode of meningitis.Etiology of deafness - the patient has no history of cochlear malformation or reported craniofacial malformations.The patient did not received pre-implant immunizations.Perioperative antibiotics (ancef and bacitracin irrigation) were administered.The receiver stimulator was not drilled to the dura and no surgical complications were reported.A csf leak occurred post operatively.The meningitis episode occurred within 30 days of a neurologic procedure.No vp shunts or lumbar drains were utilized at the onset of meningitis.Prior to meningitis, there were no signs of inflammation, fluid in the inner ear, middle ear or mastoid cavity.The patient did not have a prior upper respiratory infection or otitis media prior to meningitis.The patient's csf cultures were positive for klebsiella and pcr analysis also showed klebsiella.

• 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: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6864057
• MDR Text Key: 86078682
• Report Number: 6000034-2017-01693
• Device Sequence Number: 1
• Product Code: MHE
• UDI-Device Identifier: 09321502020404
• UDI-Public: (01)09321502020404(11)160504(17)180504
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2018
• Device Model Number: ABI541
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Life Threatening; Required Intervention