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); Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported a lost connection processor with receiver part.No in vivo assessment report was received.However, testing were performed prior to explantation in quang duc ha noi office, in (b)(6) 2021, and connection problem with the implant was identified.The neuro zti evo implant serial number (b)(4) was explanted on (b)(6) 2021 and was returned to (b)(6) for evaluation.The review of the device history record confirmed that the neuro zti evo implant serial number (b)(4) was within specification when released to our inventory in (b)(6) 2020.The returned device was examined visually and under binocular magnifier at appropriate magnification.The electrode array was restored curvy and surgical tool marks were noticeable.These damages probably occurred during explant surgery.An unusual external brazing aspect was visualized at the gold / ceramic interface.The functionality of the electrodes was tested and were compliant and met the specifications except for the impedance measurements of the electrodes in a saline solution where all the values were below the specifications.No electronic failure was found.The silicone overmolding was removed and the implant case was tested for leak according to our procedure: test revealed an hermeticity issue.This issue probably caused the ingress of moisture inside the implant casing during the period of use and would explain the connection issues.The implant case was opened, and a visual examination of the electronic part was performed.Some traces of humidity were noted on the electronic part.The hermeticity issue most probably results from a manufacturing process problem, which in turn led to a hermiticity failure of the capsule.This issue has been addressed out of us through voluntary field corrective action (vfca) # (b)(4).Udi: (b)(4).
Event or Problem Description
The customer reported that the connection between the processor and the receiver part was lost.
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 customer reported a lost connection processor with the receiver part.No in-vivo assessment report was received.However, testing was performed in (b)(6) 2021 prior to explantation (in (b)(6) office), , and a connection problem with the implant was identified.The neuro zti evo implant serial number (b)(6) was explanted on (b)(6) 2021 and was returned to oticon medical - neurelec (france) for evaluation.The returned device was examined visually and under binocular magnifier at appropriate magnification.The electrode array was restored curvy and surgical tool marks were noticeable.These damages probably occurred during explant surgery.An unusual external brazing aspect was visualized at the gold / ceramic interface.The functionality of the electrodes was tested, and they were compliant and met the specifications, except for the impedance measurements of the electrodes in a saline solution where all the values were below the specifications.No electronic failure was found.The silicone overmolding was removed and the implant case was tested for leak according to our procedure: a test revealed an hermeticity issue.This issue probably caused the ingress of moisture inside the implant casing during the period of use and would explain the connection issues.The implant case was opened, and a visual examination of the electronic part was performed.Some traces of humidity were noted on the electronic part.The reported event most probably results from a manufacturing process problem, which in turn led to the observed hermiticity failure of the capsule.The review of the device history record confirmed that the neuro zti evo implant serial number (b)(6) was within specification when released to our inventory in (b)(6) 2020.A capa #cpa-2021-00012 has been open to determine the root causes of this hermeticity failure.Corrective actions have been implemented in order to solve the issue.The subject device is part of the voluntary field corrective action initiated for neuro zti on (b)(6) 2021 (international recall #211014).
Event or Problem Description
The customer reported that the connection between the processor and the receiver part was lost.

• 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 de saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 14874380
• Report Number: 3016743107-2022-00001
• Device Sequence Number: 17550641
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201103(17)231103
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P200021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 11/03/2023
• Device Model Number: NEURO ZTI EVO
• Device Catalogue Number: M80185
• Device Lot Number: 20-04817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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 Age: 3 YR
• Patient Sex: Unknown