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

Model Number	NEURO ZTI EVO
Medical Device Problem Codes	Failure to Read Input Signal (1581); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
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 not explanted as of the date of this report.Currently, this event is not a serious injury.Follow-up reports will be submitted once explant is scheduled and device is received.The subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th 2021 (international recall #211014).
Event or Problem Description
In vivo tests were performed on (b)(6) 2022 by oticon medical representative.Oticon medical representative reported a sudden loss of hearing.Electrical artefacts measurements and impedance measurements could not be performed due to the inability to connect the neuro zti evo implant, serial number (b)(4) to the sound processor.
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 subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th 2021 (international recall #211014).
Event or Problem Description
In vivo tests were performed on (b)(6) 2022 by oticon medical representative.Oticon medical representative reported a sudden loss of hearing.Electrical artefacts measurements and impedance measurements could not be performed due to the inability to connect the neuro zti evo implant, serial number (b)(6) to the sound processor.

• 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 saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 15474642
• Report Number: 3016743107-2022-00013
• Device Sequence Number: 2918992
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201123(17)231123
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P200021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/23/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-05205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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