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

Model Number CI-1600-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Reaction (2414)

Event Date 01/31/2019

Event Type  Injury  

Event Description

The recipient is reportedly experiencing an infection at the implant site.The recipient was prescribed antibiotics, however, presented with hives due to an allergic reaction.The surgeon recommended taking benadryl.The recipient was placed on an iv for 1 week and antibiotics for 2 weeks.The recipient's activation went well.The recipient is in the process of healing.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's implant site has reportedly healed.This is the final report.

Manufacturer Narrative

The recipient's infection reportedly resolved, however, the recipient presented with oozing.The cause of the oozing was unknown.The recipient remained on antibiotics for 3 weeks.The recipient's device was activated and it went well.The recipient underwent 2 minor wound procedures and was given antibiotics for 2 weeks.The recipient is now experiencing pain at the implant site.The recipient has an appointment with an infections specialist.

Manufacturer Narrative

The recipient is reportedly doing better, but is still experiencing some pain.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: delilah garcia ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 8375976
• MDR Text Key: 137360919
• Report Number: 3006556115-2019-00069
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2019

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: 07/31/2021
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/02/2019; 05/10/2019; 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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: 48 YR