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

Model Number SONATA

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2015

Event Type  Injury  

Event Description

In situ measurements performed during the activation appointment showed 8 electrode channels in status high.No accident is reported.Pt will be seen again in 3 weeks.

Manufacturer Narrative

(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for eval.When available, a device failure analysis will be submitted as a f/u report.

Manufacturer Narrative

According to the currently available information, it appears there is a problem with the active electrode, most likely due to device minute mobility as the number of channels with high impedance is increasing over time.However to determine an exact root cause a device investigation at the explanted device is necessary.A date for explantation surgery has not been fixed yet.

Event Description

In-situ measurements performed during the activation appointment of the external processor showed 8 electrode channels in status high.No accident is reported.

Manufacturer Narrative

Conclusion: damage to the active electrode likely caused by minute device mobility was determined to have led to device failure over time.The investigation results appear to match the problems mentioned in the patient report.This is a final report.

Event Description

In-situ measurements performed during the activation appointment of the external processor showed 8 electrode channels in status high.No accident is reported.As per new information received latest in situ measurements show 11 channels with high impedance.The patient was re-implanted with a cochlear implant.

• 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: 4867784
• MDR Text Key: 6061875
• Report Number: 9710014-2015-00452
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONATA
• Other Device ID Number: (01) 09008737049119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2015
• 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: 33 MO