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

Model Number CI-1500-01

Device Problems Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Physical Property Issue (3008)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reportedly experienced an unsuccessful electrode insertion during initial implant surgery.The surgeon was not able to identify the correct place of insertion and after several attempts, the electrode array was damaged.The patient was not implanted.The patient will be implanted in the contralateral side.

Manufacturer Narrative

The recipient was implanted on the contralateral side with another advanced bionics cochlear device.

Manufacturer Narrative

Add'l info.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The company was informed that the explanted device will not be returned to the company for analysis.A review of the device history record noted no rework.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE 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: 6233377
• MDR Text Key: 64180111
• Report Number: 3006556115-2016-00590
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2017; 05/10/2017; 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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: 28 MO