MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (L24)

Device Problem Extrusion (2934)

Patient Problem No Code Available (3191)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced extrusion of the device, subsequently the receiver-stimulator was explanted on (b)(6) 2017 and the electrode array was left in-situ.

• Brand Name: NUCLEUS HYBRID L24
• Type of Device: NUCLEUS HYBRID 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: 6759111
• MDR Text Key: 81557499
• Report Number: 6000034-2017-01446
• Device Sequence Number: 1
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)161130(17)181130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: CI24RE (L24)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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
• Patient Age: 75 YR