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

Model Number NEURO ZTI EVO

Device Problems Electrical /Electronic Property Problem (1198); Defibrillation/Stimulation Problem (1573)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/23/2023

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 neuro zti evo 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).

Event Description

The oticon medical reprensentative reported : "during troubleshooting session at clinic in (b)(6), poland: patient reports unable to use implant since april due to sudden onset of painful shocking sensation and ipsilateral facial nerve stimulation (fns) when placing sound processor on head.External equipment was exchanged but did not resolve the problem.On (b)(6) 2023, using clinic sound processor, unable to run impedances without patient immediately removing sound processor due to painful shocking sensation and fns.Since three different sets of equipment have produced the same result, additional in-vivo troubleshooting is not warranted given the painful symptoms produced.The implant is clearly not operating within specifications and should be replaced under warranty." at this stage, the date of the scheduled explantation was not communicated.

• 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 saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 17779372
• MDR Text Key: 323799689
• Report Number: 3016743107-2023-00022
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-04875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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