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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The user sustained a trauma on the region of the implant.Following the incident the user could no longer hear with the device.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.In addition, a short circuit between two implant channels was present since implantation for undetermined reasons.Furthermore, during removal surgery it was discovered that five channels migrated out of cochlea.A contribution of the reported trauma and/or the reported cochlea anomaly to the migration cannot be excluded.The implant registration card states a full insertion at the time of implantation.The problems given in the recipient report appear to match the damage found.Other mechanical damages seen during investigation are attributable to the removal surgery.This is a final report.
Event or Problem Description
The user sustained a trauma on the region of the implant.Following the incident the user could no longer hear with the 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: 9977062
• Report Number: 9710014-2020-00235
• Device Sequence Number: 2968346
• Product Code: MCM
• UDI-Device Identifier: 09008737093976
• UDI-Public: (01)09008737093976(11)161123(17)191123
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: Health Professional
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 06/17/2020
• 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: 4 YR