MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR NUCLEUS FREEDOMWITH CONTOUR ADVANCE ELECTRODE; COCHLEAR IMPLANT

Model Number C124RE(CA)

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2016

Event Type  malfunction  

Event Description

During bilateral cochlear implant procedure, first implant was opened and inspected by physician; implant electrode was found to have come in packaging with a kink in it; the implant was not used and the patient was not harmed.

• Brand Name: COCHLEAR NUCLEUS FREEDOMWITH CONTOUR ADVANCE ELECTRODE
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): COCHLEAR LIMITED; 13059 e peakview ave; englewood CO 80111
• MDR Report Key: 5649735
• MDR Text Key: 45009097
• Report Number: 5649735
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2017
• Device Model Number: C124RE(CA)
• Device Catalogue Number: Z60353
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR