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

Model Number CI-1400-01

Device Problem Extrusion (2934)

Patient Problems Itching Sensation (1943); Swelling (2091); Discharge (2225)

Event Date 12/05/2017

Event Type  Injury  

Event Description

The recipient is reportedly experiencing device extrusion.The recipient presented with tenderness, swelling, itching, and drainage at the implant site.No signs of infection were observed, however, the recipient was prescribed augmentin prophylactically.Skin graft surgery is scheduled.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced skin dehiscence with the device slightly exposed.On (b)(6) 2017, the recipient was prescribed augmentin.The recipient underwent a skin graft surgery on (b)(6) 2017.The recipient was recommended device non-use for 1 week.The recipient has resumed device use.The recipient is doing well.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: 7166676
• MDR Text Key: 96443537
• Report Number: 3006556115-2017-00705
• 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
• 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: 09/30/2013
• Device Model Number: CI-1400-01
• 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: 09/16/2011
• 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: 34 YR