MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number SONATA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Failure of Implant (1924); Tissue Damage (2104)

Event Date 03/09/2019

Event Type  Injury  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The user has been explanted on (b)(6) 2019.According to the device explant report form the electrode array was not in the cochlea but in the pneumatized air cells posterior to the carotid canal since the initial surgery.

Manufacturer Narrative

Based on the information received from the field, the active electrode was not inserted into the cochlea during initial implantation but was reportedly found in the pneumatized air cells posterior to the carotid canal.A revision surgery to insert the active electrode into the cochlea was unsuccessful due to scar tissue, hence the device was explanted.The explanted device has not been received for investigation yet.

Event Description

The user has been explanted on march 09, 2019.According to the device explant report form the electrode array was not in the cochlea but in the pneumatized air cells posterior to the carotid canal since the initial surgery.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 8420207
• MDR Text Key: 138776991
• Report Number: 9710014-2019-00218
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Device Catalogue Number: 04917
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 17 YR