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

Model Number	NEURO ZTI EVO
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the "implant was not working anymore".
Additional Manufacturer Narrative
The customer reported that the "implant was not working anymore".An in vivo assessment was realised on march 31st 2022, impedance measurement was compliant for 19 of the 20 electrodes.A lost of communication was noticed, rendering the various other tests impossible.Udi : (b)(4).
Event or Problem Description
The customer reported that the "implant was not working anymore".
Additional Manufacturer Narrative
The customer reported that the "implant was not working anymore".An in vivo assessment was realised on march 31st 2022, impedance measurement was compliant for 19 of the 20 electrodes.A lost of communication was noticied, rendering the various other tests impossible.Udi : (b)(4).

• 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 saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 14876168
• Report Number: 3016743107-2022-00004
• Device Sequence Number: 5831645
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201130(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/25/2023

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?: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/25/2023
• 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 Age: 72 YR
• Patient Sex: Unknown