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

Model Number NEURO ZTI

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2023

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 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.At this stage, the serial number has not been communicated.

Event Description

At this stage, the customer did not report the reasons for explantation of the device.The planned explantation date has not been communicated.Waiting for information.Neurelec - oticon medical will assume destructive analysis can begin 10 days following issuance of this initial incident report, unless the national competent authority contacts neurelec - oticon medical within this time frame opposing a destructive analysis of the device.

• Brand Name: NEURO ZTI COCHLEAR IMPLANT
• Type of Device: NEURO ZTI
• 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: 18424408
• MDR Text Key: 331783792
• Report Number: 3016743107-2024-00001
• Device Sequence Number: 1
• Product Code: MCM
• 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: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NEURO ZTI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• 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