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

Model Number CI-1500-04

Device Problems Electrical /Electronic Property Problem (1198); Incorrect, Inadequate or Imprecise Result or Readings (1535); Electro-Static Discharge (2149)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2021

Event Type  malfunction  

Event Description

The recipient reportedly experienced loss of lock.Device testing revealed abnormal results.External equipment was exchanged, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The device passed external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The no lock condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.Electrical troubleshooting performed revealed a short between the power node and electrode ground case, and a short between the voltage ground and electrode ground case inside the analog chip.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 electrostatic 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.A corrective action was implemented.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The device passed external visual and photographic imaging inspection.System lock could not be obtained at any spacing.The device passed the mechanical tests performed.Electrical troubleshooting performed revealed a short between the power node and electrode ground case, and a short between the voltage ground and electrode ground case inside the analog chip.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 electrostatic 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.A corrective action was implemented.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• 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: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 11547944
• MDR Text Key: 243103902
• Report Number: 3006556115-2021-00264
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016873720
• UDI-Public: (01)07630016873720(11)200608(17)230131
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• 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: 33 MO
• Patient Sex: Female