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

Model Number CI24RE (L24)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device not returned to manufacturer.

Event Description

Per the clinic, the patient experienced poor performance with device use, subsequently the device was explanted on (b)(6) 2016 and the patient was re-implanted with a new device during the same surgery.

Manufacturer Narrative

Correction: the correct initial "date of this report" is 10/28/2016, not 10/31/2016, as initially reported.

Manufacturer Narrative

This report is submitted january 13, 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 (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial CO 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6095071
• MDR Text Key: 59715107
• Report Number: 6000034-2016-02246
• Device Sequence Number: 1
• Product Code: PGQ
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2016

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: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2016
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/22/2016; 01/12/2017
• 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: 72 YR