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

Model Number MI1200 SYNCHRONY PIN

Device Problem Output Problem (3005)

Patient Problems Cyst(s) (1800); Failure of Implant (1924)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to 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 had a swelling 5 times since implantation on the right side.After the last episode of swelling it was noted that the recipient is no hearing from the concerned right side.An x-ray was performed and showed that the implant is tilted anteriorly and the electrode lead is no longer in the bony channel.

Event Description

The user has had a swelling 5 times since implantation on the right side.After the last episode of swelling it was noted that the recipient is not hearing from the concerned right side.The hearing loss was sudden.Re-implantation is planned but no date has been set yet.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.Further it is reported that the implant appears tilted most likely due to an external impact.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered, but no date has been scheduled yet.This is a final report.

Manufacturer Narrative

Conclusion: based on the received information from the field a damage to the active electrode caused by excessive mechanical stress seems likely.However due to the device's received status an exact location for the suspected electrode damage cannot be determined.Further it is reported that the recipient experienced several swellings at the implant site since implantation, and that the implant appears tilted.After review of the histopathology report, a cystic formation in the implant area rather than an infection seems likely.Such formation seems to have involved the area in which the lead was recessed, thus leading over time to a possible electrode dislocation, contributing to the damage indicated by the in-situ measurements.The problems described in the recipient report seem to match the damage found.This is a final report.

Event Description

The user has had a swelling 5 times since implantation on the right side.After the last episode of swelling it was noted that the recipient is not hearing from the concerned right side.The hearing loss was sudden.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10222795
• MDR Text Key: 197340955
• Report Number: 9710014-2020-00356
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR