MAUDE Adverse Event Report: ADVANCED BIONICS IMPLANT, COCHLEAR

Model Number UNKNOWN DEVICE

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that patient's device had been dead for about five years due to inactivity.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANT, COCHLEAR
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): ADVANCED BIONICS
• MDR Report Key: 17516404
• MDR Text Key: 321049283
• Report Number: MW5123353
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN DEVICE
• Patient Sequence Number: 1