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

Model Number CI-1600-04

Device Problem Mechanical Problem (1384)

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The recipient is reportedly experiencing loss of sound and open electrodes with some swelling and bruising at the implant site.The recipient was prescribed antibiotics.A ct scan has been scheduled.

Manufacturer Narrative

Revision surgery has been scheduled.

Manufacturer Narrative

The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

On (b)(6) 2017 the recipient was reportedly prescribed ceftin (250 mg tablet), 1 tablet orally every 12 hours for 7 days.

Manufacturer Narrative

The device passed the external visual inspection.The photographic imaging inspection revealed broken electrode wires at the fantail region.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The scanning electron microscopy analysis revealed tensile breaks at all electrode wires in the fantail region.The photographic imaging inspection and scanning electron microscopy analysis revealed all wires were broken in the fantail region.It is believed that these breaks caused the loss of sound reported.Advanced bionics will continue to monitor for failure modes of this type and will implement corrective actions as necessary.This is the final report.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355 ; 6613621741
• MDR Report Key: 6461974
• MDR Text Key: 71829864
• Report Number: 3006556115-2017-00168
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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: 90 YR