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

Model Number CI-1500-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091); Swelling/ Edema (4577)

Event Date 03/18/2020

Event Type  Injury  

Event Description

The recipient is reportedly experiencing a skin flap infection.The recipient is presenting with swelling.The recipient was recommended hospitalization.The recipient's site was drained.The recipient is undergoing anti-inflammatory treatment in the hospital.

Manufacturer Narrative

The recipient's medical issue reportedly resolved.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Additional information: section b.3, d.7 on (b)(6) 2020, the recipient's infection site was drained.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral ear.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.Additional treatment details will not be provided.The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

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: 9941885
• MDR Text Key: 187007653
• Report Number: 3006556115-2020-00195
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)180213(17)200131
• 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: 03/19/2020

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: 01/31/2020
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/06/2020; 08/20/2020; 10/07/2020; 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3 YR