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

Model Number NEURO ZTI CLA

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 03/16/2022

Event Type  Injury  

Event Description

Oticon medical representative reported a connectivity issue with the implant (b)(4).

Manufacturer Narrative

This product is neither marketed nor distributed in the us; none was shipped / commercially used in the us.In vivo tests were performed by oticon medical representative on april 2022 and connectivity issue with the cochlear implant neuro zti cla, serial number (b)(4) was observed.Udi : (b)(4).

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.Follow-up report will be submitted once the root cause identified.The subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th 2021 (international recall #211014).

Event Description

Oticon medical representative reported a connectivity issue with the implant (b)(4).The customer did not report the reasons of the explantation.

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).

Event Description

Oticon medical representative reported a connectivity issue with the implant (b)(6).The customer did not report the reasons of the explantation.

• Brand Name: NEURO ZTI COCHLEAR IMPLANT
• Type of Device: 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 de saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 15138118
• MDR Text Key: 304719484
• Report Number: 3016743107-2022-00007
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 03663227801842
• UDI-Public: (01)03663227801842(11)201102(17)231102
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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,Followup
• Report Date: 10/31/2022

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: 11/02/2023
• Device Model Number: NEURO ZTI CLA
• Device Catalogue Number: M80184
• Device Lot Number: 20-04758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/20/2021; 09/20/2022
• Supplement Dates FDA Received: 10/29/2022; 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• 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