MAUDE Adverse Event Report: ADVANCED BIONICS LLC COCHLEAR IMPLANT/HI/FOCUS SLIM J; IMPLANT, COCHLEAR

Model Number CI-1601-05

Device Problems Disconnection (1171); Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Date 04/10/2023

Event Type  Injury  

Event Description

Patient already had a previous implanted cochlear implant (ci) that the wire had disconnect from the ci.Surgeon's plan was to reattach the existing wire to the existing ci.However, he was unable to maintain this reattachment.He then stated that he had not seen this before and therefore, concluded that the existing ci and/or wire had to be defective.At this point, the existing ci was explanted and the new one implanted.

• Brand Name: COCHLEAR IMPLANT/HI/FOCUS SLIM J
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): ADVANCED BIONICS LLC
• MDR Report Key: 16770834
• MDR Text Key: 313643273
• Report Number: MW5116818
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American