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

Model Number CI-1400-01

Device Problem Programming Issue (3014)

Patient Problem No Code Available (3191)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly experienced loss of sound.External equipment was exchanged and programming adjustments were made, however, issue was not resolved.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 cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration shorting across electrical components.This device had moisture that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis and dye penetrant data, it is determined that this device was non-hermetic, and that the root cause of the excessive moisture was a leak through the feed thru seals.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: 7162468
• MDR Text Key: 96487510
• Report Number: 3006556115-2017-00706
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2011
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/07/2018; 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2009
• 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