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

Model Number CI-1500-04

Device Problem Extrusion (2934)

Patient Problems Abscess (1690); Bruise/Contusion (1754)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).

Event Description

The recipient reportedly experienced a bruise at the implant site.The recipient was treated with antibiotic and anti-inflammatory.The recipient underwent surgical drainage.During surgical drainage, an abscess was identified in the right mastoid region.The recipient was administered iv antibiotics to treat coagulase-negative staphylococcus.The recipient is now reportedly experiencing device extrusion.

Manufacturer Narrative

Revision surgery will be scheduled.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain additional information regarding recipient status and explant details were unsuccessful.This is the final report.

Manufacturer Narrative

The recipient's device was reportedly explanted.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed 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.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient was reportedly reimplanted with another advanced bionics cochlear device indicating the recipient's medical issues resolved.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: brooke lopez ; 28515 westinghouse place; valencia, CA 91355 ; 6613624711
• MDR Report Key: 7430378
• MDR Text Key: 105516143
• Report Number: 3006556115-2018-00170
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SV
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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: 6 YR