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

Model Number SONATA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Meningitis (2389)

Event Date 09/22/2019

Event Type  Injury  

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 Description

The user was admitted to the clinic on (b)(6) 2019 due to severe headache, intermittent fever and seizures.The user reported first suspected cerebral spinal fluid (csf) leak 3-4 weeks post-implantation and was hospitalized due to severe headache and intermittent fever.Surgery was done on (b)(6) 2018 to seal the cochleostomy or any source of csf leak.As per information received in (b)(6) 2020, meningitis was confirmed before revision surgery through multiple lumbar taps which were taken.The parents reported improvement in hearing and speech therapy progress since implantation.According to the field, even despite the issues the user seemed to be doing well.The user will be explanted.

Manufacturer Narrative

Additional information: according to available information, the observed csf leakage is most likely due to surgical and anatomical reasons i.E.Incomplete partition of the cochlea associated with csf gusher at implantation and recurrent leakage.Meningitis has been confirmed and its development was most likely facilitated by the combination of several factors i.E.The presence of cochlear anomalies, csf leakage and mastoiditis.Furthermore a short circuit between two implant channels is present for undetermined reasons.Explantation is considered, but no date has been scheduled yet.

Event Description

At implantation on (b)(6) 2018, during the cochleostomy, it was observed that there was a lot of perilymphatic fluid coming out of the cochlea.The cochleostomy was completely sealed, electrode inserted up to marker ring, and fascia was used to better seal the cochleostomy.First suspected cerebral spinal fluid (csf) leak was reported 3-4 weeks post-implantation and the user was hospitalized due to severe headache and intermittent fever.Surgery was done on (b)(6) 2018 to seal the cochleostomy or any source of csf leak.The first week on (b)(6) 2019, the user was hospitalized due to headache and fever; csf leak was observed after a fever.On (b)(6) 2019, the user was hospitalized again with the same symptoms probably due to a viral infection.During all hospitalizations lumbar tap procedures were done to check for csf infection.Results showed increase white blood cells (wbc).The user was admitted to the clinic on (b)(6) 2019 due to severe headache, intermittent fever and seizures.Another surgery was scheduled for on (b)(6) 2019.In situ measurements were performed multiple times during the surgery which suggested that the implant was working within normal limits.It was thought that the infection could have been from a different route (e.G.Hematologic) and not due to the presence of the device.It was also seen that the infection was in the mastoid area (not in the inner ear), and that the eustachian tube was more open than usual.A valsalva test was done multiple times to check for any leak from the oval window, round window and cochleostomy (completely sealed).No leak was found during the surgery.In the end, the device remained implanted.The surgeon decided to close both the eustachian tube and ear canal to prevent future infections.After more than a month, the patient was doing well.The recipient was admitted again at hospital at the beginning on (b)(6) 2020.During the most recent hospitalization, the user was given a weaker antibiotic but was very responsive.The user has fully recovered and was discharged from the hospital.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 9933385
• MDR Text Key: 186733066
• Report Number: 9710014-2020-00223
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2020
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3 YR