MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number CI-1500-04

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2020

Event Type  Injury  

Event Description

The recipient reportedly experienced device migration.The recipient underwent repositioning surgery on (b)(6) 2020.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient is successfully using the device.No further details will be provided.This is the final report.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10616771
• MDR Text Key: 209532084
• Report Number: 3006556115-2020-01022
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016861710
• UDI-Public: (01)07630016861710(11)181204(17)210930
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR