MAUDE Adverse Event Report: ADVANCED BIONICS LLC. ADVANCED BIONICS AB ULTRA V1; IMPLANT, COCHLEAR

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Advanced bionics ultra v1 device was released in 2019 and the manufacturer issued a stop ship shortly thereafter.At our hospital we had 18 devices implanted prior to the stop ship, and as of today 9 of those have failed and required revision.Reference reports: mw5153763, mw5153764, mw5153765, mw5153767, mw5153768, mw5153769, mw5153770, mw5153771.

• Brand Name: ADVANCED BIONICS AB ULTRA V1
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): ADVANCED BIONICS LLC.
• MDR Report Key: 19095984
• MDR Text Key: 340242182
• Report Number: MW5153766
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1