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

Model Number CI-1400-02H

Device Problem Electrical Shorting (2926)

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

Event Date 08/01/2017

Event Type  malfunction  

Event Description

The recipient is reportedly experiencing open and shorted electrodes and decreased performance.Revision surgery is scheduled.

Manufacturer Narrative

The recipient was reportedly reimplanted with another advanced bionics cochlear device.

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 severed near the array prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed multiple broken electrode wires at the fantail.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical tests performed.The device passed the mechanical tests performed.The scanning electron microscopy analysis of the electrode revealed evidence of fatigue breaks on multiple wires at the fantail region.The photographic imaging inspection and the scanning electron microscopy analysis revealed evidence of fatigue breaks on multiple electrode wires at the fantail region.These breaks can be associated with the decrease in performance and the impedance failures reported.A corrective action was implemented.This is the final report.

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 revealed broken electrode wires near the fantail.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical tests performed.This is an interim 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
• MDR Report Key: 7870286
• MDR Text Key: 120307133
• Report Number: 3006556115-2018-00431
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2011
• 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 Age: 10 YR