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

Model Number CI-1500-01

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In (b)(6) 2016, the recipient reportedly experienced trauma at the implant site causing a seroma.In (b)(6) 2016, a drainage and flap procedure was performed.The recipient did well following the procedure.Advanced bionics is in the process of gathering additional information.Once additional information becomes available a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The recipient reportedly underwent a drainage procedure in (b)(6) 2016.On (b)(6) 2016, the recipient underwent flap revision surgery.Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly did well following the procedures.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: 6596166
• MDR Text Key: 76125893
• Report Number: 3006556115-2017-00312
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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: 6 YR