MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-05

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Hearing Impairment (1881); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  Injury  

Event Description

The recipient is reportedly experiencing retention issues due to device migration.External equipment was exchanged, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

The recipient is reportedly a non-user of the device due to lack of benefit.A review of the recipient¿s test data indicated impedance issues.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Additional information: sections b.3 & d.6b.The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.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.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The suspected device migration was not confirmed prior to revision surgery.The external visual inspection revealed damaged silicone on the top and bottom covers, and the electrode was severed at the fantail and near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode pocket revealed no anomalies within the electrode pocket.The scanning electron microscopy analysis of the electrode lead and array revealed no anomalies along the lead or within the array.This device was explanted for medical reasons.The device passed the tests performed.This version of the ultra device is no longer distributed.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 ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9720681
• MDR Text Key: 179786039
• Report Number: 3006556115-2020-00057
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862267
• UDI-Public: (01)07630016862267(11)190423(17)220430
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR