MAUDE Adverse Event Report: OTICON MEDICAL - NEURELEC NEURO ZTI COCHLEAR IMPLANT; NEURO ZTI EVO

Model Number NEURO ZTI EVO

Device Problems Failure to Read Input Signal (1581); Communication or Transmission Problem (2896)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

While this device has gained initial pma approval, it has not been commercialized, imported or sold in the us and no implantations have been performed as of the date of this report.The implant neuro zti evo was not explanted as of the date of this report.Currently, this event is not a serious injury.Follow-up reports will be submitted once explant is scheduled and device is received.The subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th 2021 (international recall #211014).

Event Description

In vivo analysis was performed on may 18th, 2022 by oticon medical representative.Oticon medical representative reported the impossibility to connect with the neuro zti evo implant, serial number (b)(4) despite changes in cable, antenna, magnet and sound processor.Electrical artefacts measurements and impedance measurements could not be performed due to the inability of connection with the device.

• Brand Name: NEURO ZTI COCHLEAR IMPLANT
• Type of Device: NEURO ZTI EVO
• Manufacturer (Section D): OTICON MEDICAL - NEURELEC; 2720, chemin saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• Manufacturer Contact: adrian ternisien ; 2720, chemin de saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 15474241
• MDR Text Key: 306341559
• Report Number: 3016743107-2022-00014
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201109(17)231109
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P200021
• 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
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-04875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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