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

Model Number CI-1500-04

Device Problems Electromagnetic Interference (1194); Device Sensing Problem (2917); Naturally Worn (2988)

Patient Problems Pain (1994); Swelling (2091)

Event Date 07/11/2018

Event Type  malfunction  

Event Description

The recipient reportedly experienced a displaced magnet.The recipient presented with pain and swelling.The recipient received medical treatment.On (b)(6) 2018, the recipient underwent magnet replacement surgery.The recipient healed, however, the device was not recognized in the programming software.The recipient ceased device use.

Manufacturer Narrative

The recipient is reportedly experiencing loss of lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery is scheduled.

Manufacturer Narrative

Programming adjustments were made, however, the issue did not resolve.The recipient's activation went well.

Event Description

The recipient reportedly experienced a displaced magnet.The recipient presented with pain and swelling.On (b)(6) 2018, the recipient underwent magnet replacement surgery.The recipient healed, however, the device was not recognized in the programming software.The recipient ceased device use.

Manufacturer Narrative

The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was only obtained at certain spacing.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.This is an interim report.

Manufacturer Narrative

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

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.This is the final report.

Manufacturer Narrative

The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was only obtained at certain spacing.The electrode condition prevented some of the electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to a short from the power node to the case ground at the analog chip.It is believed that electrode static discharge (esd) led to an overload voltage, damaging structures on the case ground node inside the analog integrated circuit.This ultimately caused the device to cease functioning.

• Brand Name: HIRES 90K¿ ADVANTAGE 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: 7720662
• MDR Text Key: 115059594
• Report Number: 3006556115-2018-00351
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016828638
• UDI-Public: (01)07630016828638(11)150116(17)171031
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/24/2018; 10/17/2018; 11/07/2018; 12/06/2018; 12/12/2018; 01/10/2019; 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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: 74 YR