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

Model Number CI-1500-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

The pt reportedly experiences pain with and without device use.The pt also experiences swelling with itchiness.The pt was prescribed norentin for pain and aerius as an antihistamine.The pt continues to be monitored.

Manufacturer Narrative

The patient's pain has reportedly resolved.This is the final report.This report may be required by medical device reporting regulations contained in title 21 part 803.As provided in the title 21 section 803.16, it does not establish any causal relationship between this device and any event associated with use of the device, nor does advanced bionics® intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K ADVANTAGE IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS LLC; 12740 san fernando rd; sylmar CA 91342
• Manufacturer Contact: pamela campo ; 28515 westinghouse place; valencia, CA 91355 ; 6613627624
• MDR Report Key: 4510149
• MDR Text Key: 5411175
• Report Number: 3006556115-2015-00036
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2015

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: 12/31/2015
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2014
• 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