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); Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Oticon medical representative reported a connectivity issue with the implant (b)(4).
Additional Manufacturer Narrative
This product is neither marketed nor distributed in the us; none was shipped / commercially used in the us.In vivo tests were performed by oticon medical representative on april 2022 and connectivity issue with the cochlear implant neuro zti cla, serial number (b)(4) was observed.Udi : (b)(4).
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 root cause identified.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
Oticon medical representative reported a connectivity issue with the implant (b)(4).The customer did not report the reasons of the explantation.
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
Oticon medical representative reported a connectivity issue with the implant (b)(6).The customer did not report the reasons of the explantation.

• 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 de saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 15138118
• Report Number: 3016743107-2022-00007
• Device Sequence Number: 14887096
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)201102(17)231102
• 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
• 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,Followup,Followup
• Report Date (Section B): 10/31/2022

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: 11/02/2023
• Device Model Number: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 20-04758
• 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: 04/07/2021
• Supplement Date Received by Manufacturer: 09/20/2021; 09/20/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/29/2022; 10/31/2023
• 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