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

Model Number CI-1500-01

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2018

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing loss of lock and facial nerve stimulation.Programming adjustments were made, however, the issue did not resolve.The recipient ceased device use.Revision surgery is under consideration.

Manufacturer Narrative

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

Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the array and tool marks were observed on the top and bottom covers prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed severed electrode wires.This is believed to have occurred during revision surgery.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 an electrical test performed.The scanning electron microscopy analysis revealed tool marks on the seam weld.The failure of this device is attributed to a short from the power node to the case ground at the analog chip.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on the case ground node inside the analog integrated circuit.This ultimately caused the device to cease functioning.In addition, this device had nitrogen that exceeded the limit.Based on an assessment of the residual gas analysis test data and feedthru dye penetrant inspection, it is determined that this device was non-hermetic, and that the root cause of the excessive nitrogen was a leak through the feedthru seals.Due to the presence of moisture getter, no signs of moisture were observed.This is the final report.

Manufacturer Narrative

Revision surgery is reportedly scheduled.

• 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: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 7687164
• MDR Text Key: 114157553
• Report Number: 3006556115-2018-00313
• 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: 06/22/2018

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: 11/30/2015
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/12/2018; 11/12/2018; 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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 Age: 6 YR