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

Model Number CI-1500-01

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Purulent Discharge (1812); Fistula (1862); Failure of Implant (1924)

Event Type  Injury  

Event Description

The recipient reportedly experienced otomastoiditis followed by electrode extrusion.The recipient presented with purulent discharge.The recipient underwent a cleaning of the conduit with aspiration.During explant surgery, a fistulous orifice was observed in the posterior wall of the auditory canal.The recipient's device was explanted.The recipient will be reimplanted at a later date.

Manufacturer Narrative

Additional information regarding recipient treatment will not be provided.The recipient's wound has reportedly healed.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's device will reportedly not return to advanced bionics for analysis.A review of the device history record was completed and no anomalies were noted. this is the final report.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.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
• MDR Report Key: 7711650
• MDR Text Key: 114755230
• Report Number: 3006556115-2018-00322
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)141009(17)160930
• Combination Product (y/n): N
• Reporter Country Code: VE
• 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,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2014
• 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): Required Intervention