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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  malfunction  

Event Description

It was reported that at the pt's fourth fitting appointment, on (b)(6) 2014, in situ measurements showed normal results.At an appointment held on (b)(6) 2014, in situ measurements showed 11 electrode channels with status hi.Pt's parents reported that the pt was always falling and that currently a bruise is present on the forehead towards non implanted side.The parents reported that the pt kept pulling the audio processor for the last 10 days.An x-ray showed the electrode array to the be intra-cochlear.Re-implantation is being considered.

Manufacturer Narrative

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

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: SONATA
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; fuerstenweg 77a; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4384795
• MDR Text Key: 5124149
• Report Number: 9710014-2014-00726
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• 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
• Report Date: 12/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 24M