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

Model Number CI-1500-01

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Burning Sensation (2146)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing intermittent lock.The recipient presented with stinging at the implant site.External equipment was exchanged, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

Revision surgery is scheduled.

Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the fantail, and damaged silicone overmold was observed on both top and bottom covers prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained intermittently at certain spacing.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.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed near the fantail and damaged silicone overmold was observed on both top and bottom covers prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained intermittently at certain spacing.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The residual gas analysis revealed nitrogen above the limit indicating a non-hermetic device.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.A corrective action was implemented.In addition, this device had nitrogen that exceeded the limit.Based on an assessment of the residual gas analysis data and the dye penetrant, it is believed 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

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

• 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: 8104398
• MDR Text Key: 128588868
• Report Number: 3006556115-2018-00584
• 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,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2014
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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: 9 YR