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

Model Number CI-1400-02H

Device Problem Impedance Problem (2950)

Patient Problem Hearing Impairment (1881)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly experienced loss of sound and invalid impedances.External equipment was exchanged, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

The date of this report is corrected to 12/08/2017.

Manufacturer Narrative

The external visual inspection revealed the electrode array was severed prior to receipt as well as a damaged silastic overmold on the bottom cover.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.This is an interim report.

Manufacturer Narrative

The external visual inspection revealed the electrode array was severed prior to receipt as well as damaged silastic overmold on the bottom cover.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock 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 hybrid visual inspection revealed non-conductive epoxy encroachment on an electrical component.The failure of this device is attributed to a short from a power node to the electrode ground case at the analog chip.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on the electrode ground node inside the analog integrated circuit.This ultimately caused the device to cease functioning.In addition, a significant drop in signal strength as well as elevated resistance was measured across an electrical component joint.Corrective actions were implemented.This is the final report.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355 ; 6613624711
• MDR Report Key: 7152185
• MDR Text Key: 95965285
• Report Number: 3006556115-2017-00714
• 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
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2013
• 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: 6 YR