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

Model Number	NEURO ZTI EVO
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional 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.Follow-up report will be submitted once the root cause determined.The subject device is part of the voluntary field corrective action initiated for neuro zti on (b)(6) 2021 (international recall #211014).
Event or Problem Description
Oticon medical representative reported that the patient could hear nothing while using speech processor on the left side since the problem occured: a sudden decrease of performance.Oticon medical representative reports also an impact on the implant with hematoma.In vivo analysis performed by the oticon medical representative on (b)(6), 2022 revealed infinite impedance on 18 out of 20 electrodes.

• Brand Name: NEURO ZTI COCHLEAR IMPLANT
• Common Device Name: NEURO ZTI EVO
• 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: 17314469
• Report Number: 3016743107-2023-00013
• Device Sequence Number: 4036544
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201103(17)231103
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P200021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/03/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-04819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown