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

Model Number CI-1500-01

Device Problem Extrusion (2934)

Patient Problems Pain (1994); Skin Discoloration (2074)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The recipient reportedly experienced trauma at the implant site, resulting in pain and skin discoloration.The recipient was prescribed cedax for ten days and steroids.There was no improvement and the recipient experienced serohematic secretion and the recipient was prescribed amoxiclav.The recipient then presented with device extrusion.The recipient's device was explanted.

Manufacturer Narrative

The recipient was reimplanted with another advanced bionics cochlear device.The recipient is reportedly doing well with the new device.

Manufacturer Narrative

The recipient was reportedly discharged with cefadroxil for ten days following explant surgery.The recipient is well and the newly implanted device was activated.

Manufacturer Narrative

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection has reportedly resolved.The company was informed that the explanted device is lost and will not be returned to the company.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: 5413959
• MDR Text Key: 37610543
• Report Number: 3006556115-2016-00022
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: VE
• 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: 01/15/2016

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: Lay User/Patient
• Device Expiration Date: 03/31/2015
• 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: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2016; 05/12/2016; 06/08/2016; 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• 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: 9 YR