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

Model Number MI1200 SYNCHRONY

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

Patient Problems Death (1802); Meningitis (2389)

Event Date 07/03/2017

Event Type  Death  

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

It was reported that the bilaterally implanted patient passed away due to pneumococcal meningitis.

Manufacturer Narrative

Conclusions: according to the received information, the patient had abnormal cochlear structures and cerebrospinal fluid leak at implantation surgery, which is generally associated with an increased risk of meningitis even without a history of otosurgery.In particular, cerebrospinal fluid leaks represent a known risk factor for pneumococcal meningitis.Even though a complete vaccination has been reported, the pneumococcal vaccine currently available covers only part of the existing serotypes which could potentially cause the infection.Further, if this passes from the middle ear to the inner ear, e.G.Through an open communication due to a malformation, the risk of meningitis remains high even after proper immunization.Finally, a review of the device's sterilization records confirms that proper sterilization was applied at the time of manufacturing.Considering the delayed onset and the preexisting congenital deformity, a contribution of the device to the reported event can be most likely excluded.This is a final report.

Event Description

It was reported that the bilateral patient passed away due to pneumococcal meningitis.The patient was admitted to the hospital on (b)(6) 2017 and died on (b)(6) 2017.The patient was bilaterally implanted with +form24 electrode arrays.Ct and mri during pre-assessment showed widened vestibular aqueducts, bilateral cochlear deformity and poorly visible auditory nerves.Bilateral csf leaks occurred during surgery.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 6688901
• MDR Text Key: 79119850
• Report Number: 9710014-2017-00554
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Other Device ID Number: (01) 09008737308940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 3 YR