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

Model Number CI-1500-01

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Sepsis (2067)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The recipient reportedly experienced a wound gap with sepsis and device migration.On (b)(6) 2016, the recipient underwent resuturing, however, the implant remained visible through the incision.On (b)(6) 2017, the recipient underwent a flap rotation revision surgery.The recipient was treated with iv antibiotics for 7 days, however, the issue did not resolve.The recipient's device was explanted.The recipient was not reimplanted.The recipient's implant site is healed.

Manufacturer Narrative

(b)(4).The device passed both the external visual and photographic imaging inspections.System lock was verified.The device passed all of the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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: 6539282
• MDR Text Key: 74252950
• Report Number: 3006556115-2017-00223
• 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
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2016
• 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