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

Model Number CI-1600-04

Device Problem Defective Component (2292)

Patient Problem Swelling (2091)

Event Date 02/19/2019

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing open electrodes.The recipient is presenting with swelling.The recipient was recommended to cease device use.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed near the array and an electrode ground ring sleeve was dislodged prior to receipt.These are believed to have occurred during revision surgery.In addition, all broken electrode wires were observed on the fantail region.The photographic imaging inspection confirmed all broken electrode wires at the fantail region.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode revealed tensile breaks on all wires.The photographic imaging inspection revealed all broken electrode wires between the fantail and the electrode ground ring regions.It is believed that these breaks caused the open impedances induced by the head trauma reported.Advanced bionics will continue to monitor failure modes of this type.This is the final report.

Event Description

The recipient is reportedly experiencing open electrodes following a head trauma event.The recipient was recommended to cease device use.Revision surgery will be scheduled.

Manufacturer Narrative

Revision surgery is reportedly scheduled.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8429102
• MDR Text Key: 139300441
• Report Number: 3006556115-2019-00099
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170418(17)200430
• 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
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 MO