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

Model Number NEURO ZTI EVO

Device Problems Failure to Read Input Signal (1581); Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  Injury  

Event Description

A decrease in performance is noticed with the neuro zti implant, serial number (b)(4) by an oticon medical representative following a call from one of the dutch implantion centers, erasmus rotterdam.Oticon medical representative reported a sudden loss of communication after a brief humming and buzzing sound between the implant and the sound processor.

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 patient is using a neuro 2 sound processor.Various trouble shooting steps were performed to confirm if the sound processor is the cause of the connectivity issues.This hypothesis has been discarded.Futhermore, the implant neuro zti evo 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.

Event Description

A decrease in performance is noticed with the neuro zti implant, serial number (b)(6) by an oticon medical representative following a call from one of the dutch implantion centers, erasmus rotterdam.Oticon medical representative reported a sudden loss of communication after a brief humming and buzzing sound between the implant and the sound processor.The device was explanted.

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 #211014).

• Brand Name: NEURO ZTI COCHLEAR IMPLANT
• Type of Device: 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: 15334214
• MDR Text Key: 302957334
• Report Number: 3016743107-2022-00009
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 03663227801859
• UDI-Public: (01)03663227801859(11)201130(17)231130
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P200021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other