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

Model Number MI1210 SYNCHRONY ST

Device Problem Output Problem (3005)

Patient Problems Failure of Implant (1924); Irritation (1941)

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 parent's reported that the user lost benefit hearing more than one month ago.The skin was reddish over the implant, which is thought to be caused by the magnet strength ( magnet strength 3).The user is reported to have thin skin and therefore magnet strength 2 is thought to be more appropriate.There have been no recent changes of health or medication or any report of trauma.

Manufacturer Narrative

Conclusion: damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.The problems given in the recipient report appear to match the damage found.Other mechanical damages found during investigation, are attributable to the removal surgery.This is a final report.

Event Description

The parent's reported that the user lost hearing benefit with the device more than one month ago (around (b)(6)).There have been no recent changes of health or medication or any report of trauma.The user was re-implanted on (b)(6) 2019.

• 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: 9150221
• MDR Text Key: 163191364
• Report Number: 9710014-2019-00737
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737331825
• UDI-Public: (01)09008737331825
• 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: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 5 YR