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

Model Number	NEURO ZTI CLA
Medical Device Problem Codes	Failure to Read Input Signal (1581); Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In vivo analysis was performed on november 9th, 2022 by the oticon medical representative.No impedance measurements could be made due to the lack of communication with the internal part.Similarly, electrode integrity testing and peae testing could not be performed due to the lack of communication with the cochlear implant.On (b)(6) 2022 : the connection between the sound processor and the implant has been restored.The oticon medical representative reported that the impedance measurements were conform to specifications.The problem seemed to have been solved.The implant was received on (b)(6) 2023.The explantation date was not communicated and was estimated on (b)(6) 2023.The reasons for the explantation were not provided by the customer.
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.Follow-up report will be submitted once the investigation is complete.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 analysis was performed on (b)(6), 2022 by the oticon medical representative.No impedance measurements could be made due to the lack of communication with the internal part.Similarly, electrode integrity testing and peae testing could not be performed due to the lack of communication with the cochlear implant.On (b)(6) 2022 : the connection between the sound processor and the implant has been restored.The oticon medical representative reported that the impedance measurements were conform to specifications.The problem seemed to have been solved.The implant was received on (b)(6), 2023.The explantation date was not communicated and was estimated on (b)(6) 2023.The reasons for the explantation were not provided by the customer.
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 #(b)(4).

• Brand Name: NEURO ZTI COCHLEAR IMPLANT
• Common Device Name: NEURO ZTI CLA
• 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: 17507891
• Report Number: 3016743107-2023-00017
• Device Sequence Number: 12287540
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)201102(17)231102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 11/02/2023
• Device Model Number: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 20-04757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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