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

Model Number CI-1500-01

Device Problem Extrusion (2934)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The recipient reportedly experienced an infection at the implant site.The recipient presented with pus and pain.The recipient underwent revision surgery on (b)(6) 2017.The recipient then experienced eruption and thinning of the skin.The recipient underwent surgery on( b)(6) 2017.Soon after, the recipient presented with pus and blood and underwent another surgery on (b)(6) 2017.The recipient later experienced device extrusion.The recipient's device was explanted on (b)(6) 2018.The recipient will be reimplanted at a later date.

Manufacturer Narrative

The recipient's symptoms reportedly began (b)(6) 2017 at the skin flap.The recipient underwent wound debridement in addition to being explanted.The recipient was prescribed antibiotics post-explant surgery.

Manufacturer Narrative

The recipient's infection is reportedly resolving.

Manufacturer Narrative

The recipient's infection has resolved.The external visual inspection revealed the electrode array was severed and cuts on the silastic overmold of the top cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.

• Brand Name: HIRES 90K¿ ADVANTAGE 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 ; 6613624711
• MDR Report Key: 7467361
• MDR Text Key: 106698386
• Report Number: 3006556115-2018-00183
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: BD
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2018

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: 09/30/2018
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2018; 06/20/2018; 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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: 14 YR