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

Model Number CI-1500-01

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 08/17/2020

Event Type  Injury  

Event Description

The recipient reportedly experienced a displaced magnet during a mri.The recipient presented with pain.Proper bandaging protocol was not followed.On (b)(6) 2020, the magnet was surgically replaced with a new magnet.The recipient is in the process of healing.

Manufacturer Narrative

The recipient reportedly healed and resumed device use.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The recipient's internal magnet was received on january 20, 2021.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 device remains implanted.The magnet passed the visual inspection.The magnet passed the gauss measurement test.The magnet passed the tests performed.No corrective action is indicated.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 ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 10531986
• MDR Text Key: 206861732
• Report Number: 3006556115-2020-00947
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)181214(17)201130
• 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,Followup,Followup
• Report Date: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/23/2020; 02/10/2021; 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR