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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per information received from the surgeon, the user inserted a cotton swab into their ear causing extrusion of the electrode array.The user was re-implanted, achieving a complete insertion with the 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
Per information received from the surgeon, the user inserted a cotton swab into their ear causing extrusion of the electrode lead in the external auditory canal.Reportedly, the electrode array was fully inserted in the cochlea.The user was re-implanted, achieving a complete insertion with the new device.The electrode lead of the explanted device was reportedly cut off.
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, the recipient inserted a cotton swab into the external ear canal (eac) inadvertently causing an extrusion of the electrode lead.Reportedly the recipient has a radical cavity.The electrode array was still fully inserted in the cochlea and hearing performance was good before explantation surgery.This is a final report.
Event or Problem Description
Per information received from the surgeon, the user inserted a cotton swab into their ear causing extrusion of the electrode lead in the external auditory canal.Reportedly, the electrode array was fully inserted in the cochlea.There was no allegation against the device.The user had good hearing benefit before explantation.The user was re-implanted, achieving a complete insertion with the new device.The electrode lead of the explanted device was reportedly cut off.Despite requested, the explanted device could not yet be returned for investigation.
Additional Manufacturer Narrative
Additional information: according to the information received, the recipient inserted a cotton swab into the external ear canal (eac) inadvertently causing an extrusion of the electrode lead.Reportedly the recipient has a radical cavity.The electrode array was still fully inserted in the cochlea and hearing performance was good before explantation surgery.The explanted device has not been received for investigation yet.

• 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: 14165522
• Report Number: 9710014-2022-00285
• Device Sequence Number: 14955256
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2022

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: 01/29/2024
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 08841
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 04/14/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/05/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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: 83 YR
• Patient Sex: Male