MAUDE Adverse Event Report: OTICON MEDICAL - NEURELEC COCHLEAR IMPLANT; Implant, cochlear

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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 was explanted.The subject device is part of the voluntary field corrective action initiated for neuro zti on (b)(6) 2021 (international recall #211014).

Event Description

The chru reports "we have a cochlear implant explant to return to you".The date of explantation, the reason of explantation, the implant type and serial number were not communicated.

• Brand Name: COCHLEAR IMPLANT
• Type of Device: Implant, cochlear
• Manufacturer (Section D): OTICON MEDICAL - NEURELEC; 2720, chemin saint-bernard; porte 14; vallauris 06220
• Manufacturer Contact: charlotte desbrosse ; 2720, chemin saint-bernard; porte 14; vallauris, 06220 ; FR 06220
• MDR Report Key: 18957869
• MDR Text Key: 338305845
• Report Number: 3016743107-2024-00009
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P200021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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