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)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The oticon medical representative reported that the patient suddenly stopped hearing.In vivo analysis was performed on (b)(6) 2023.Communication issue was highlighted with the cochlear implant.The planned explantation date has not been communicated.Neurelec - oticon medical will assume destructive analysis can begin 10 days following issuance of this initial incident report, unless the national competent authority contacts neurelec - oticon medical within this time frame opposing a destructive analysis of the device.
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 cla 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).

• 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 (Section G): 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: 18425525
• Report Number: 3016743107-2024-00002
• Device Sequence Number: 7771962
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)210111(17)240111
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: P200021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/11/2024
• Device Model Number: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 21-00112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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
• Patient Sex: Unknown