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

Model Number CI-1400-01

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 03/01/2016

Event Type  Injury  

Event Description

The recipient is reportedly experiencing a central perforation with recurrent otorrhea.The recipient was prescribed antibiotics and anti-inflammatories, however, the issue did not resolve.Surgery for mastoid clearing and exploration will be scheduled.Revision surgery is under consideration.

Manufacturer Narrative

The recipient's device was explanted.The recipient will be reimplanted at a later date.

Manufacturer Narrative

The external visual inspection of the device 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 one of the electrical tests from being performed.The device passed all of the electrical and mechanical tests performed.The residual gas analysis resulted in a nitrogen level above the limit.The device was explanted for medical reasons.The device passed the electrical tests performed.However, this device had nitrogen that exceeded the limit.Based on an assessment of the residual gas analysis test data, it is determined that this device was non-hermetic.Due to the presence of moisture getter, no signs of moisture were observed.A corrective action has been implemented.

Manufacturer Narrative

(b)(4).The recipient's infection has reportedly resolved and the tympanic membrane perforation is completely healed.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: 5457758
• MDR Text Key: 38962004
• Report Number: 3006556115-2016-00046
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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,Followup,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 4 YR