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

Model Number CI532

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 07/17/2017

Event Type  malfunction  

Event Description

The patient stated device made a lot of noise and unclear sounds.The device was explanted and a new device implanted.

• Brand Name: NUCLEUS
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED; 13059 e peakview ave.; centennial CO 80111
• MDR Report Key: 6759748
• MDR Text Key: 81602493
• Report Number: 6759748
• Device Sequence Number: 1
• Product Code: LXB
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CI532
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2017
• Event Location: Home
• Date Report to Manufacturer: 07/18/2017
• 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 Outcome(s): Other
• Patient Age: 66 YR