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

Model Number CI-1400-01

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  Malfunction  

Event Description

The recipient is reportedly experiencing loss of lock. Revision surgery will be scheduled.

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 broken antenna coil wires. The photographic imaging inspection confirmed broken antenna coil wires. 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 some of the electrical tests performed. The device passed the mechanical tests performed. This device had broken antenna coil wires. A corrective action was implemented. 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: delilah garcia ; 28515 westinghouse place; valencia, CA 91355 ; 6613624711
• MDR Report Key: 7152046
• MDR Text Key: 96061025
• Report Number: 3006556115-2017-00699
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (Y/N): N
• Reporter Country Code: IN
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,FOREIGN
• Reporter Occupation: PATIENT
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/28/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 10/31/2014
• Device MODEL Number: CI-1400-01
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/03/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/26/2012
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial