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

Model Number CI-1500-04

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Neuropathy (1983)

Event Date 08/07/2018

Event Type  Injury  

Event Description

The recipient is reportedly experiencing poor performance secondary to auditory neuropathy.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

The recipient was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient reportedly had a fluid bubble under the surface of the implant.

Manufacturer Narrative

The device passed the external visual and photographic imaging inspections.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.

Manufacturer Narrative

The external visual inspection revealed delamination between the silastic overmold and a section of the bottom cover of the device.This created a void which was filled with fluid of undetermined origin, and had the appearance of a blister.Silastic overmolding serves only as a transition barrier between the titanium implant case and the tissue of the patient.It does not serve as an additional layer of sealing of the internal device and thus has no impact on hermeticity or the electrical functionality of the device.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7683568
• MDR Text Key: 113866317
• Report Number: 3006556115-2018-00309
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2013
• 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: 9 YR