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

Model Number CI-1400-01

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problems Head Injury (1879); Failure of Implant (1924)

Event Date 10/01/2020

Event Type  Injury  

Event Description

The recipient is reportedly experiencing a displaced magnet following an mri.The recipient mri was performed in (b)(6) 2020.The mri bandaging protocol was not followed.Device testing revealed results within normal limits.Magnet replacement surgery will be scheduled.

Manufacturer Narrative

The recipient reportedly underwent magnet replacement surgery on (b)(6) 2021.The recipient resumed device use.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's explanted magnet was reportedly discarded and will not return to advanced bionics for analysis.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 11871347
• MDR Text Key: 252324774
• Report Number: 3006556115-2021-00669
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2013
• Device Model Number: CI-1400-01
• 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: 61 YR