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 Codes	Failure of Implant (1924); Ear Pain (4812)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
In vivo analysis was performed on august 11th, 2022 by the oticon medical representative.The oticon medical representative reported a sudden stopping of implant in (b)(6) 2022.No impact reported by parents and relatives.The patient complained of pain and lack of sound.The patient is prone to epileptic seizures on a regular basis and may have fallen during one of his seizures.An impedance measurement was obtained but was not reproducible.Communication difficulties with the implant occured during the test.The patient experienced pain during the impedances measurement attempts and was unwilling to continue with the entire examination.The test was performed with a reference sound processor.
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 reports will be submitted once explant is scheduled and device is received.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
In vivo analysis was performed on (b)(6) 2022 by the oticon medical representative.The oticon medical representative reported a sudden stopping of implant on (b)(6) 2022.No impact reported by parents and relatives.The patient complained of pain and lack of sound.The patient is prone to epileptic seizures on a regular basis and may have fallen during one of his seizures.An impedance measurement was obtained but was not reproducible.Communication difficulties with the implant occured during the test.The patient experienced pain during the impedances measurement attempts and was unwilling to continue with the entire examination.The test was performed with a reference sound processor.
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).Note: explantation date was estimated.

• 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: 15803382
• Report Number: 3016743107-2022-00016
• Device Sequence Number: 5471464
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)201130(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P200021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 11/16/2022

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: 11/30/2023
• Device Model Number: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 20-05369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown