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

Model Number Z285654

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2018

Event Type  malfunction  

Event Description

The cochlear implant was placed in the patient and when it is time to check the implant if it is functioning properly, with the use of the pairing device which is placed inside a sterile probe cover.In the middle of the case dr.Asked for the cochlear implant.Device was implanted.The implant is not working.Dr.Head and neck, tried several times but still the implant would not work.He decided to explant the implant device.He ordered for the back up cochlear implant to be opened.He tested it with the pairing device and it worked properly.He instructed or staff to send back the defective implant device to the manufacturer.Called the implant coordinator (b)(6) to come in the room to send back the defective implant device straight to the manufacturer.Asked for the charge nurse assistance regarding the matter.Charge nurse called back and said that risk management approved that the implant device can be sent back straight to the manufacturer.Implant rep clinical territory manager was informed by (b)(6) regarding the defective implant device.No harm or any complications was done on the pt.Procedure went smoothly until the very end of the surgery.Risk manager approved released of implant to manufacturer perioperative manager.Manufacturer response for cochlear implant, cochlear americas (per site reporter).Risk management does not receive written responses.The perioperative manager will receive the report.

• Brand Name: NUCLEUS
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): COCHLEAR LIMITED; 13059 e peakview ave; centennial CO 80111
• MDR Report Key: 8183895
• MDR Text Key: 131004069
• Report Number: 8183895
• 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: 12/18/2018

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: Z285654
• Device Catalogue Number: Z285654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Date Report to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 77