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

Model Number CI-1400-01

Device Problems Migration or Expulsion of Device (1395); Extrusion (2934)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

Udi number: na.

Event Description

The recipient reportedly experienced device extrusion and a displaced magnet.The recipient was recommended device non-use.Revision surgery is under consideration.

Manufacturer Narrative

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 electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device failed the residual gas analysis test limit.This device was explanted for medical reasons.The device passed the electrical tests performed.However, this device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies from this vendor are no longer used.This is the final report.

Manufacturer Narrative

The recipient reportedly experienced skin breakdown.The recipient's device was explanted.The recipient will be reimplanted at a later date.The explanted magnet was discarded and will not be returned to advanced bionics for analysis.

Manufacturer Narrative

The recipient is reportedly healing well.

• Brand Name: HIRES 90K¿ 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: 7152348
• MDR Text Key: 95969172
• Report Number: 3006556115-2017-00732
• 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
• Report Date: 12/01/2017

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: 08/31/2007
• Device Model Number: CI-1400-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/05/2018; 03/30/2018; 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2005
• 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: 63 YR