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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
It was reported the recipient had a csf (cerebrospinal fluid) gusher during implantation surgery.A few days after the surgery the patient had vomiting and high fever and was treated with iv antibiotics; the fever reduced.Later csf drops were coming from the nose and so it was decided to take the recipient into surgery to repair the csf leak.The repair surgery took place on (b)(6) 2018.It was subsequently reported that the patient was admitted into the hospital due to another episode of csf leakage.On (b)(6) 2018 the recipient was taken into surgery.The device was removed, the source of the csf leakage sealed and the device reinserted under general anesthesia.
Additional Manufacturer Narrative
Based on the received information from the field, the recipient experienced several episodes of csf leakage without reported meningitis.High fever was experienced by the recipient which was reportedly treated with antibiotics.Reportedly the recipient has mondini malformation which may have contributed to the post-operative csf leakage.Revision surgeries to seal the cochleostomy were performed and the recipient is reportedly doing well.Per info received the same device was re-inserted and the in situ measurements revealed a functional device.This is a final report.
Event or Problem Description
It was reported the recipient had a csf (cerebrospinal fluid) gusher during implantation surgery.A few days after the surgery the patient had vomiting and high fever and was treated with iv antibiotics; the fever reduced.Later csf drops were coming from the nose and so it was decided to take the recipient into surgery to repair the csf leak.The repair surgery took place on (b)(4) 2018.It was subsequently reported that the patient was admitted into the hospital due to another episode of csf leakage.On (b)(4) 2018 the recipient was taken into surgery.The device was removed, the source of the csf leakage sealed and the device reinserted under general anesthesia.Additional information received stat that the recipient is doing fine without any further problems.

• 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: 7705728
• Report Number: 9710014-2018-00560
• Device Sequence Number: 732091
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: 24 MO