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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
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 underwent a revision surgery on (b)(6) 2021 to try a re-insertion of the electrode array which migrated out from the cochlea.The full active electrode array migrated.It was decided to re-implant the user with a new device during the surgery.
Additional Manufacturer Narrative
Conclusions: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report the active electrode migrated postoperatively outside of the cochlea.During device investigation damage of in the electrode array due to device minute mobility was found, which was most likely caused by re-insertion attempts during revision surgery.Therefore it was decided to explant the device.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user underwent a revision surgery on (b)(6) 2021 to try a re-insertion of the electrode array which migrated out from the cochlea.The full active electrode array migrated.Based on intra-operative measurements it was decided to reimplant with a new device.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 12120320
• Report Number: 9710014-2021-00486
• Device Sequence Number: 4817066
• Product Code: MCM
• UDI-Device Identifier: 09008737062743
• UDI-Public: (01)09008737062743
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 07/21/2021

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 Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR