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

Model Number C1-1500-04

Device Problems Biofilm coating in Device (1062); No Device Output (1435)

Patient Problems Hearing Loss (1882); Unspecified Infection (1930); Swelling (2091)

Event Date 07/09/2015

Event Type  Injury  

Event Description

The patient reportedly experienced an infection at the implant site.The patient presented with swelling and inability to obtain consistent lock.The patient's device was explanted.It was reported that infection and significant biofilm were found around the device.

Manufacturer Narrative

The external visual inspection revealed a dented bottom cover and the electrode was severed near the electrode ground ring prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented one of the electrical tests 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.

Manufacturer Narrative

The patient was hospitalized on (b)(6) 2015.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The company was informed that the recipient's infection has been resolved.This is the final report.

• 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: nicole birch ; 28515 westinghouse place; valencia, CA 91355-0000 ; 6613621528
• MDR Report Key: 4972555
• MDR Text Key: 6073555
• Report Number: 3006556115-2015-00349
• 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: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: C1-1500-04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 3 YR