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

Model Number	NEURO ZTI CLA
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported : "no connection between external and internal part." the cochlear implant neuro zti cla, serial number (b)(4) was explanted.
Additional Manufacturer Narrative
This product is neither marketed nor distributed in the us; none was shipped / commercially used in the us.In vivo tests prior explantation were performed by oticon medical representative on june 9th, 2022 and despite different antennas, magnets and sound processor, no connection with the cochlear implant neuro zti cla, serial number (b)(4) was possible.Udi : (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 prior explantation were performed by oticon medical representative on june 9th, 2022 and despite different antennas, magnets and sound processor, no connection with the cochlear implant neuro zti cla, serial number (b)(6) was possible.Udi : (b)(4).The customer reported that there was no connection between the sound processor and the cochlear implant.In vivo tests prior explantation were performed by the oticon medical representative on june 9th, 2022 and confirm the issue reported by the customer : indeed, despite different antennas, magnets and sound processor changes : no connection with the cochlear implant was possible.The neuro zti cla implant serial number (b)(6) was explanted on (b)(6) 2022 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 not restored, and surgical tool marks were noticeable.These damages probably occurred during explant surgery.Therefore, the functionality of the electrodes could not be tested on the returned device.However, impedance measurement and signal control on feedthrough level have been carried out.The device was tested compliant during all possible tests.No electronic failure was found.The silicone over-molding was removed and the implant case was tested for leak according to our procedure: test revealed an hermeticity issue, an unusual external brazing aspect was visualized at the gold / ceramic interface.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 whitish traces 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.The review of the device history record confirmed that the neuro zti cla implant serial number (b)(6) was within specification when released to our inventory in january 2021.A capa #cpa-2021-00015 has been open to determine the root causes of this hermeticity failure.Corrective actions have been implemented in order to solve the issue.A voluntary field corrective action was initiated on october 14th 2021, oticon medical reference is # (b)(4).
Event or Problem Description
The customer reported : "no connection between external and internal part.".The cochlear implant neuro zti cla, serial number (b)(6) was explanted.

• 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: 15066152
• Report Number: 3016743107-2022-00005
• Device Sequence Number: 5628229
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)210118(17)240118
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 06/05/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/18/2024
• Device Model Number: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 21-00261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown