MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number CI-1600-05

Device Problems Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problems Failure of Implant (1924); Therapeutic Effects, Unexpected (2099); Fibrosis (3167)

Event Date 12/20/2018

Event Type  Injury  

Event Description

The recipient reportedly experienced poor performance and non-auditory sensations.On (b)(6) 2018 the recipient underwent surgery.During surgery, fibrosis tissue was observed on the electrode array.According to the surgeon, the tissue development could explain the electrode migration.The surgeon experienced difficulties during surgery and explanted the device.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's activation reportedly went well.The device was lost and will not return to the company for analysis.A review of the device history record was completed and no anomalies were noted.This is the final report.

Event Description

The recipient reportedly experienced electrode migration.The recipient presented with poor performance and non-auditory sensations.On (b)(6) 2018 the recipient underwent surgery.During surgery, fibrosis tissue was observed on the electrode array.According to the surgeon, the tissue development could explain the electrode migration.The surgeon experienced difficulties during surgery and explanted the device.The recipient was reimplanted with another advanced bionics cochlear device.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 8240950
• MDR Text Key: 132858210
• Report Number: 3006556115-2018-00638
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016844584
• UDI-Public: (01)07630016844584(11)180518(17)210531
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

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: 05/31/2021
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR