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

Device Problems Unintended Collision (1429); No Device Output (1435)

Patient Problems Head Injury (1879); Hearing Loss (1882)

Event Type  malfunction  

Event Description

The pt suffered an impact to the head and has no access to sound any more, pt was having access to sound before the incident.

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.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: SONATA
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck, tirol ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck, tirol A-602-0 ; AU A-6020 ; 77885626
• MDR Report Key: 4487654
• MDR Text Key: 18546436
• Report Number: 9710014-2015-00081
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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: 01/23/2015
• 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