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

Model Number CI-1500-01

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Swelling (2091)

Event Date 12/01/2019

Event Type  Injury  

Event Description

The recipient reportedly experienced redness and swelling at the implant site.The recipient was recommended to cease device use till full resolution, however, the issue recurred.The recipient was seen by a doctor for a puncture treatment.The recipient was then hospitalized on (b)(6) 2020 to undergo a swelling cleaning operation.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient has recovered well.The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.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: 10317352
• MDR Text Key: 200188863
• Report Number: 3006556115-2020-00664
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016872495
• UDI-Public: (01)07630016872495(11)190412(17)210331
• 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
• Report Date: 07/03/2020

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: 03/31/2021
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/28/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24 MO