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

Model Number CI-1400-02H

Device Problem Extrusion (2934)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The recipient's is reportedly experiencing device extrusion.The recipient was administered a shot of penicillin and prescribed a penicillin ointment for topical use over the area.The recipient was recommended device non-use.The recipient is reportedly healing.

Manufacturer Narrative

The recipient has resumed device use.

Manufacturer Narrative

The recipient reportedly underwent a bilateral otomicroscopy.The recipient was prescribed keflex post-operatively for 14 days and was instructed to continue antibiotic ointment daily.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Additional details regarding treatment and recipient status will not be provided.The recipient remains implanted.This is the final report.

• Brand Name: HIRES 90K¿ IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355 ; 6613621741
• MDR Report Key: 7166285
• MDR Text Key: 96445373
• Report Number: 3006556115-2017-00703
• 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: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2011
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2009
• 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