MAUDE Adverse Event Report: ADVANCED BIONICS, LLC; COCHLEAR IMPLANT

Device Problems Improper Device Output (2953); Moisture or Humidity Problem (2986)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Event Description

The recipient reportedly experienced sound quality issues and fluid around the implant site, typically following physical activity.The recipient was prescribed a steroid series (type unknown).The recipient's symptoms have resolved.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly did not take any medication.The recipient's symptoms resolved on their own.This is the final report.

• Brand Name: NA
• 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: 5815845
• MDR Text Key: 50230178
• Report Number: 3006556115-2016-00307
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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