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

Model Number SONATA

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 12/24/2017

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 patient suffered from an accident two months ago; he reports no more hearing sensation with the device.Re-implantation is considered.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.An impact is mentioned in the recipient's report.However to confirm an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is being considered, but no surgery date has been communicated.Additionally, it is reported that one electrode was not inserted at initial implantation.

Event Description

The recipient was involved in an accident two months ago; he reports that he no longer has any hearing sensation with the device.Re-implantation is considered.

Manufacturer Narrative

Damage to the active electrode, likely caused by minute device mobility, was determined to have led to device failure over time.Also, the reported accident might have weakened the fixation of the active electrode and could also be a factor for electrode mobility.Additionally, it is reported that one electrode contact was not inserted at initial implantation.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.

Event Description

The recipient was involved in an accident two months ago; he reports that he no longer has any hearing sensation with the device.The recipient was re-implanted.

• 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: 7150499
• MDR Text Key: 96018873
• Report Number: 9710014-2017-01119
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• 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: 08/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/24/2017
• 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: 4 YR