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

Model Number NEURO ZTI EVO

Device Problem Insufficient Information (3190)

Patient Problem Tinnitus (2103)

Event Date 09/21/2023

Event Type  Injury  

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 explanted.The subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th 2021 (international recall #211014).

Event Description

The customer reported : "sensations of crackling by the patient despite new settings made." the cochlear implant neuro zti evo, serial number (b)(6) was explanted on (b)(6) 2023.

• 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: charlotte desbrosse ; 2720, chemin saint bernad; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 18082516
• MDR Text Key: 327475417
• Report Number: 3016743107-2023-00027
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201124(17)231124
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P200021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/24/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-05235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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