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

Model Number MI1000 MED-EL CONCERT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

Patient Problems Headache (1880); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported that the patient requested explantation due to ongoing pressure and discomfort following implantation.The pressure is described as feeling of fullness and pressure in the implanted ear.The patient cannot tolerate sound stimulation and the presence of the device, but the symptoms are not alleviated by removing the audio processor.Patient's performance is poor but steady.No trauma or accident were reported.A surgery is planned, but not scheduled yet.

Manufacturer Narrative

Not available for this device.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 analysis will be submitted as a follow up report.

Manufacturer Narrative

(b)(4).Conclusions: based on measurements performed on the device whilst it was implanted and during explant investigation, and considering the fact that the reported problems could not be alleviated by removing the audio processor, it must be assumed that the device was explanted most likely due to a device unrelated clinical issue.However, the latter cannot be determined as the reported problems seem to have solved after re-implantation.This is a final report.

Event Description

It was reported that the patient requested explantation due to ongoing pressure and discomfort following implantation.The pressure is described as a feeling of fullness in the implanted ear.The patient cannot tolerate sound stimulation and the presence of the device, but the symptoms are not alleviated by removing the audio processor.Patient_s performance was poor but steady and the patient received benefit from the device when using it consistently.Neither trauma nor accident was reported.

• 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: 4321909
• MDR Text Key: 5246761
• Report Number: 9710014-2014-00626
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737083632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 71 YR