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

Model Number CI-1500-02H

Device Problems Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 09/26/2019

Event Type  malfunction  

Event Description

The recipient is experiencing intermittent lock.External equipment was exchanged and programming adjustments were made, however the issue did not resolve.Revision surgery is 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 a surgical tool mark was observed on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at a certain spacing with a sound processor.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The internal visual inspection revealed encroachment of non-conductive epoxy on an electrical component (kovar tab).The reported complaint of no lock was confirmed during the analysis of this device.Elevated resistance was measured across an electrical component (kovar tab), which is believed to be related to the loss of lock.A corrective action was implemented.This is the final report.

Manufacturer Narrative

The external visual inspection revealed that the electrode was severed near the array, and a surgical tool mark was observed on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at certain spacing with a sound processor.The electrode condition prevented some of the electrical tests performed.The device passed some of the electrical and mechanical tests performed.This is an interim report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

The external visual inspection revealed that the electrode was severed near the array, and a surgical tool mark was observed on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at a certain spacing with a sound processor.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.This is an interim 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: 9087563
• MDR Text Key: 165035903
• Report Number: 3006556115-2019-00553
• Device Sequence Number: 1
• Product Code: MCM
• 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,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Model Number: CI-1500-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2019; 12/17/2019; 01/28/2020; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR