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

Model Number CI532

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

Prosthesis (ci532) would not fit the patient's anatomy properly so a different model (ci522) was used and surgery was able to be completed properly.Product had patient contact but no patient harm.Manufacturer response for cochlear implant, (brand not provided) (per site reporter).Product was returned to manufacturer.

• Brand Name: NUCLEUS
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR AMERICAS; 13059 e peakview ave; centennial CO 80111
• MDR Report Key: 8599337
• MDR Text Key: 144703252
• Report Number: 8599337
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CI532
• Device Catalogue Number: CI532
• Device Lot Number: 1020180333320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1