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

Model Number	NEURO ZTI EVO
Medical Device Problem Codes	Communication or Transmission Problem (2896); Connection Problem (2900); Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Oticon medical representative reported a loss of communication with the cochlear implant neuro zti evo serial number (b)(4).
Additional Manufacturer Narrative
Oticon medical representative reported a loss of communication with the implant.No in vivo assessment report was received.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.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 loss of communication with the cochlear implant neuro zti evo serial number (b)(6).The device was explanted.
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 (b)(6) 2021 (international recall #(b)(4)).
Event or Problem Description
Oticon medical representative reported a loss of communication with the cochlear implant neuro zti evo serial number (b)(6).The device was explanted.

• 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 (Section G): NEURELEC / OTICON MEDICAL; 2720 chemin saint bernard; vallauris, 06220 ; FR 06220
• Manufacturer Contact: susan lambert ; 2720 chemin saint bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 14875075
• Report Number: 3016743107-2022-00002
• Device Sequence Number: 5073795
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201130(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2024

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: 11/30/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-05370
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 10/03/2022; 10/03/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/13/2022; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2020
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Unknown