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

Model Number CI-1500-04

Device Problem No Device Output (1435)

Patient Problems Hearing Loss (1882); Twitching (2172)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The recipient reportedly experienced facial twitching and loss of lock, following possible exposure to electrostatic discharge.Programming adjustments were attempted, however, the recipient showed an adverse reaction and programming was discontinued.Revision surgery is scheduled.

Manufacturer Narrative

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

Manufacturer Narrative

The external visual inspection revealed the electrode was severed along the lead prior to receipt.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 performed.The device passed several of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to a short at the analog chip.It is believed that the electrostatic discharge (esd) led to an overload voltage, damaging structures on the node inside the analog integrated chip.This ultimately caused the device to cease functioning a corrective action has been implemented.This is the final report.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: pamela campo, associate ; 6613627624
• MDR Report Key: 4798413
• MDR Text Key: 5856441
• Report Number: 3006556115-2015-00234
• 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: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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: 24 MO