MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM; PGQ

Model Number CI24RE (L24)

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hearing Impairment (1881)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed september 23, 2016.Implanted device remains.

Event Description

Per the clinic, the device was explanted on (b)(6) 2016, due to partial insertion and migration of the electrode array.The patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted january 23, 2017.

• Brand Name: NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM
• Type of Device: PGQ
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5972245
• MDR Text Key: 55418558
• Report Number: 6000034-2016-01934
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

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 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: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 76 YR