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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user's hearing performance with the device was affected.The user stated that she has no audio perception with the device anymore.The user reportedly suffered a trauma.The user was reimplanted on the (b)(6) 2022.Reinsertion attempts were unsuccessful therefore the clinic decided to implanted a new device.
Additional 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 or Problem Description
The user's hearing performance with the device was affected.The user stated that she has no audio perception with the device anymore.The user reportedly suffered a trauma.The user was reimplanted on the (b)(6) 2022.Reinsertion attempts were unsuccessful therefore the clinic decided to implanted a new device.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery due to a post-operative migration of the electrode array out of cochlea.However the re-insertion was not successful and therefore the device was explanted and the recipient was re-implanted with a new device.Reportedly the recipient suffered from a trauma, which might have contributed to the observed migration.The explanted device has not been received for investigation yet.
Event or Problem Description
The user stated that she suddenly no longer had benefit from the device.Prior to that testing revealed less hearing perception at higher frequencies.The user was re-implanted on the (b)(6) 2022.Reinsertion attempts were unsuccessful, therefore it was decided to implant a new device.A full insertion of the electrode array of the new device was achieved.
Event or Problem Description
The user stated that she suddenly no longer had benefit from the device.Prior to that testing revealed less hearing perception at higher frequencies.The user reportedly suffered a trauma.The user was re-implanted on the (b)(6) 2022.Reinsertion attempts were unsuccessful, therefore it was decided to implant a new device.A full insertion of the electrode array of the new device was achieved.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received from the field the recipient underwent a revision surgery due to a post-operative migration of the electrode array out of cochlea.However the re-insertion was not successful and therefore the device was explanted and the recipient was re-implanted with a new device.Reportedly the recipient suffered from a trauma, which might have contributed to the observed migration.This is a final report.

• 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: 13585244
• Report Number: 9710014-2022-00139
• Device Sequence Number: 5681338
• Product Code: MCM
• UDI-Device Identifier: 09008737078805
• UDI-Public: (01)09008737078805
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/20/2021
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 31113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 02/18/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/03/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2018
• 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: 36 YR
• Patient Sex: Female