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

Model Number CI-1400-02H

Device Problem Extrusion (2934)

Patient Problem No Code Available (3191)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly experienced device extrusion.The recipient's device was explanted.The recipient will not be reimplanted due to medical issues.

Manufacturer Narrative

(b)(4).Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection has reportedly resolved.This is the final report.

Manufacturer Narrative

The recipient reportedly experienced a skin flap infection.A second degree burn was observed over the implant site.On (b)(6) 2017, the recipient was prescribed mupirocin.The recipient was recommended device non-use for 2 months.Due diligence attempts to obtain additional information regarding recipient status were unsuccessful.The device passed the external visual inspection.The photographic imaging inspection revealed a broken electrode wire near the fantail.This is not believed to be related to the return reason.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.This is the final report.

• Brand Name: HIRES 90K¿ 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 ; 6613624711
• MDR Report Key: 7281384
• MDR Text Key: 100402955
• Report Number: 3006556115-2018-00052
• 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
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2011
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/30/2018; 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2009
• 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: 81 YR