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

Model Number NEURO ZTI CLA

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 09/04/2023

Event Type  malfunction  

Event Description

The oticon medical representative reported a device failure on the cochlear implant.At this stage, an explantation is suggested.The scheduled explantation date was not communicated.

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 cla was not explanted as of the date of this report.Currently, this event is not a serious injury.Follow-up report will be submitted once the device explanted.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 CLA
• 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: 17698816
• MDR Text Key: 322836785
• Report Number: 3016743107-2023-00020
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)201130(17)231130
• Combination Product (y/n): N
• Reporter Country Code: MO
• PMA/PMN Number: P200021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 20-05369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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