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 12/19/2023

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 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 chru reports " an explantation took place on december 19th, 2023".The reason of explantation and serial number were not communicated.

• 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 Contact: charlotte desbrosse ; 2720 chemin saint bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 18526362
• MDR Text Key: 333038644
• Report Number: 3016743107-2024-00005
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: NEURO ZTI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other