MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR; IMPLANT, COCHLEAR

Model Number P774600

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

Cochlear implant, model cl612, serial # (b)(4) was not able to be implanted due to defective wire - (curling and not able to be positioned correctly).This caused extra time in the operating room and the need to open another device.

• Brand Name: COCHLEAR
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED; 13059 e peakview ave; centennial CO 80111
• MDR Report Key: 9171684
• MDR Text Key: 161714279
• Report Number: 9171684
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P774600
• Device Catalogue Number: P774600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1