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 Codes	Failure of Implant (1924); No Information (3190)
Date of Event	06/29/2020
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 implant appears to have moved and the clinic is concerned about the integrity of the skin flap.Repositioning surgery is planned for the (b)(6) 2020.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the device migrated post-operatively from its initial position causing skin problems above the implant.Further the electrode array migrated out of cochlea.Reportedly the recipient has a cochlea malformation which might has contributed to the observed migration.During a re-positioning surgery the electrode could not be re-inserted due to scar tissue and was damaged whilst trying to remove tissue.The problems described in the recipient report seem to match the damage found.This is a final report.
Event or Problem Description
The implant appeared to have moved and the clinic was concerned about the integrity of the skin flap.Both the implant housing and electrode had migrated.The housing was sitting against the post auricular sulcus and only 2 electrodes were intra-cochlear.The magnet strength was reportedly deemed appropriate for the user.Therefore, the user was re-implanted with a new device.Post-op ct the next day confirmed full insertion.

• 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: 10211195
• Report Number: 9710014-2020-00352
• Device Sequence Number: 16712517
• Product Code: MCM
• UDI-Device Identifier: 09008737078805
• UDI-Public: (01)09008737078805
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 08/31/2020

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: MI1200 SYNCHRONY
• Device Catalogue Number: 31113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: 3 YR