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

Model Number CI-1500-01

Device Problems Intermittent Continuity (1121); Structural Problem (2506)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2019

Event Type  malfunction  

Event Description

The recipient reportedly experienced open circuits and intermittencies.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Programming adjustments were made, however, the issue did not resolve.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 external visual inspection revealed silicone slices on the top cover near the electrode ground ring and along the lead.In addition, the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the array.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 revealed tensile breaks along the lead near the array at some electrodes.The photographic imaging inspection and scanning electron microscopy analysis revealed broken electrode wires along the lead near the array.It is believed that these breaks caused the open impedances measured at the clinic.Advanced bionics will continue to monitor failure modes of this type.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 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 8704925
• MDR Text Key: 148432836
• Report Number: 3006556115-2019-00340
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)171027(17)190930
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR