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

Model Number CI-1500-04

Device Problem Extrusion (2934)

Patient Problem Fall (1848)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly fell and experienced a traumatic impact at the implant site.The recipient's device extruded.The recipient underwent a occipital rotation advanced flap surgery and developed edema at the implant site.The recipient continues to be monitored.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient's site has healed and the recipient continues to use the device.The recipient's device remains implanted.This is the final report.

Manufacturer Narrative

The recipient reportedly experienced recurrent dehiscence and infection at the implant site.On (b)(6) 2016, the recipient was prescribed augmentin 875mg bid for 21 days.The recipient experienced device exposure.On (b)(6) 2016, the recipient underwent a scalp debridement and rotational flap procedure.The recipient's device was explanted.The recipient was discharged (b)(6) 2016.The recipient was prescribed bactrim ds, septra ds for ten days.The recipient is reportedly healing.The recipient will be reimplanted at a later date.

Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the array 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 all of the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly healed.The recipient was reimplanted with another advanced bionics cochlear device.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: rachael perez ; 28515 westinghouse place; valencia, CA 91355 ; 6613627734
• MDR Report Key: 5651041
• MDR Text Key: 45057698
• Report Number: 3006556115-2016-00191
• 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,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2013
• 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: 89 YR