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); Intermittent Communication Failure (4038)

Patient Problem Failure of Implant (1924)

Event Date 12/22/2023

Event Type  Injury  

Event Description

The oticon medical representative reported that the patient reports a connection issue with the implant dated (b)(6) 2023.The connection cuts about once per hour.No pain issues at this patient.On december 22nd, 2023 the customer informed oticon medical that the cochlear implant was explanted and that the device was available.The explantation date is estimated.

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.Follow-up report will be submitted once the device investigation performed.The subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th, 2021 (international recall #211014).

• 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 (Section G): 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: 18451353
• MDR Text Key: 332263196
• Report Number: 3016743107-2024-00004
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P200021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-05235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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 Outcome(s): Other