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

Model Number CI-1400-01

Device Problems Device Inoperable (1663); Power Problem (3010)

Patient Problem No Code Available (3191)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient is reportedly experiencing loss of lock and increased power consumption.External equipment has been exchanged and programming adjustments were made, however, the issue is not resolved.Revision surgery will be scheduled.

Manufacturer Narrative

The recipient's device was explanted.Due to bony growth and scar tissue, the recipient was implanted with another advanced bionics cochlear device on the contralateral side.

Manufacturer Narrative

The recipient's device was reportedly not explanted.Advanced bionics considers the investigation into this reportable event as closed.It is believed that the recipient experienced an in-situ failure.A review of the device history record noted no rework.The recipient remains implanted.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: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 6426410
• MDR Text Key: 70907939
• Report Number: 3006556115-2017-00112
• 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: Audiologist
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2005
• 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: 43 YR