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

Model Number CI-1400-01

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

The recipient reportedly experienced facial nerve stimulation with device use.Programming adjustments were attempted, however, the issue was not resolved.Revision surgery will be scheduled.

Manufacturer Narrative

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

Manufacturer Narrative

The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device failed some of the electrical tests performed.The device passed the mechanical tests performed.The reported complaint of facial nerve stimulation was verified during this analysis.The failure of this device is attributed to a short at the analog chip.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on a node inside the analog integrated chip.This ultimately cause the device to cease functioning.A corrective action has been implemented.This is the final report.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342 0000
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355-0000 ; 6613627624
• MDR Report Key: 4594767
• MDR Text Key: 21834220
• Report Number: 3006556115-2015-00080
• 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,health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2013
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2012
• 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: 4 YR