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

Model Number CI-1400-01

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Edema (1820); Erythema (1840); Head Injury (1879); Pain (1994); Swelling/ Edema (4577)

Event Date 11/17/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced a displaced magnet following a head trauma incident at the implant site.The recipient presented with pain, redness, and edema.The recipient was prescribed amoxicillin clavulanate, dexamethasone, and ketorolac.The recipient ceased device use.On (b)(6) 2019, the recipient underwent magnet replacement surgery.

Manufacturer Narrative

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was activated and no further issues were reported.This is the final report.

Manufacturer Narrative

The magnet was received at the company on june 22, 2020 and is undergoing analysis.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 IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9496680
• MDR Text Key: 172208848
• Report Number: 3006556115-2019-00751
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/20/2019

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: 09/30/2017
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2020; 02/11/2020; 08/27/2020; 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 42083
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR