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

Device Problem Unintended Collision (1429)

Patient Problem Hearing Loss (1882)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

After a trauma the pt's parents noticed that the child was not hearing anymore.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 f/u report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: MED-EL CONCERT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck, tirol A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4441824
• MDR Text Key: 5379747
• Report Number: 9710014-2015-00029
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• 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: 01/08/2015
• 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: 33 MO