MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-05

Device Problems Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problems Head Injury (1879); Failure of Implant (1924)

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The recipient reportedly experienced loss of lock and sound following a head trauma incident.Device testing revealed open electrodes.Imaging revealed correct device location.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 external visual inspection revealed sliced silicone on the top and bottom covers, at the fantail region, and near the electrode ground ring.In addition, the electrode was severed along the lead.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken wires at the fantail region.In addition, cut wires were observed near the electrode ground ring which 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 and mechanical tests performed.The scanning electron microscopy (sem) analysis confirmed tensile breaks across all electrode wires at the fantail region.The photographic imaging inspection and sem analysis confirmed broken electrode wires at the fantail region.It is believed that these breaks caused the open impedances measured at the clinic.Advanced bionics will continue to monitor failure modes of this type.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¿ ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: vanessa lerma ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 14075058
• MDR Text Key: 294060728
• Report Number: 3006556115-2022-00514
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016878046
• UDI-Public: (01)07630016878046(11)201109(17)231130
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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: 21 MO
• Patient Sex: Female