MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; MI1200 SYNCHRONY

Device Problem Electrical Shorting (2926)

Patient Problem No Code Available (3191)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

In situ measurements from march 30, 2015 show all electrode channels in status high adn four involved in short circuit.No accident is reported.Reimplantation was planned for (b)(6) 2015.

Manufacturer Narrative

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: MI1200 SYNCHRONY
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; fuerstenweg 77a; innsbruck, tirol ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4723994
• MDR Text Key: 5746092
• Report Number: 9710014-2015-00279
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: (01)0900873709041(11)140828(17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• 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: 2 YR