MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; C40+

Device Problem Unintended Collision (1429)

Patient Problem Hearing Loss (1882)

Event Date 06/04/2013

Event Type  Injury  

Event Description

It was reported that the patient received an impact on the implant region.After this, there was no longer access to sound with the device.The patient was re-implanted on (b)(6) 2014.

Manufacturer Narrative

Not available for this device.The device has been explanted and should 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 COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: C40+
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck, tirol ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck, tirol ; AU ; 6460705562
• MDR Report Key: 4357324
• MDR Text Key: 5179306
• Report Number: 9710014-2014-00655
• 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: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 18 YR