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

Model Number MI1200 SYNCHRONY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 fell out of bed and hit the left implanted side of her head on a piece of furniture.The left pinna and post auricular area were impacted.A bruised was observed on the pinna.She had no sound perception with the device when she put the processor on in the morning.The surgical date for re-implantation has been scheduled.

Manufacturer Narrative

Damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.Other damages found during investigation are most likely related to explantation surgery.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The user fell out of bed and hit the left implanted side of her head on a piece of furniture.The left pinna and post auricular area were impacted.A bruise was observed on the pinna.She had no sound perception with the device when she put the processor on in the morning.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: 7128001
• MDR Text Key: 95462866
• Report Number: 9710014-2017-01076
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Other Device ID Number: (01) 09008737094041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• 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: 71 YR