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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
The user fell onto the floor hitting directly over the implant site.The fall occurred around the beginning of october after which there was swelling, and there was a bump/swollen area over the left implant site.Follow-up with the surgeon is recommended.
Additional Manufacturer Narrative
Additional information: based on the received information, damage to the active electrode due to the reported trauma appears likely.However, to determine an exact root cause, device investigation would be necessary.Imaging and follow-up with the surgeon are planned but no date has been scheduled yet.
Event or Problem Description
The user fell hitting his head on the floor directly over the implant site.The fall occurred around the beginning of (b)(6) 2021, after which there was swelling and a bump/swollen area over the left implant site.Follow-up with the surgeon and imaging is recommended but no update has been received yet.
Event or Problem Description
The user fell hitting his head on the floor directly over the implant site.The fall occurred around the beginning of (b)(6) 2021, after which there was swelling and a bump/swollen area over the left implant site.The user was to be re-implanted on the (b)(6) 2022, however, the surgery was cancelled due to covid.No new date has been set yet.
Additional Manufacturer Narrative
Additional information: based on the received information, damage to the active electrode due to the reported trauma appears likely.However, to determine an exact root cause, device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.
Additional Manufacturer Narrative
Conclusion: the investigation results revealed overload fractures in the active electrode confirming that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.
Event or Problem Description
The user fell hitting his head on the floor directly over the implant site.The fall occurred around the beginning of october 2021, after which there was swelling and a bump/swollen area over the left implant site.The user was re-implanted in (b)(6) 2022.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: 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: 12717485
• Report Number: 9710014-2021-00831
• Device Sequence Number: 19759456
• Product Code: MCM
• UDI-Device Identifier: 09008737366780
• UDI-Public: (01)09008737366780
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/16/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 10/26/2021; 10/26/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/10/2022; 06/23/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 MO
• Patient Sex: Male