MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number CI-1600-04

Device Problem Programming Issue (3014)

Patient Problem No Code Available (3191)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The recipient is reportedly experiencing sound quality issues.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.

Manufacturer Narrative

(b)(4).The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The device passed the electrical tests performed.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain details regarding treatment were unsuccessful.The recipient's pain has resolved.This is the final report.

Manufacturer Narrative

The recipient reportedly experienced pain at the implant site.The recipient's device was explanted.

Manufacturer Narrative

The recipient was reportedly not explanted.Revision surgery is scheduled.

• Brand Name: HIRES¿ ULTRA 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 ; 6613621741
• MDR Report Key: 7249938
• MDR Text Key: 99801261
• Report Number: 3006556115-2018-00024
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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: 54 YR