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

Model Number MI1200 SYNCHRONY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Hearing performance with the device was effected.Reportedly the electrode array had migrated out of the cochlea.Per internal registration information, a full insertion of the active electrode array was achieved at implantation.The patient was re-implanted with a new device on (b)(6) 2017.

Manufacturer Narrative

According to the recipient report, the device was explanted due to the active electrode array having migrated out of cochlea.A complete insertion was achieved during implantation; however 6/7 electrode channels were confirmed to be out of cochlea by imaging and at explantation surgery.Furthermore, the recipient was initially implanted with a flex24 electrode and loss of residual hearing has been recently noted; thus re-implantation was done with a longer electrode type (flex28).The problems given in the recipient report appear to match these findings.This is a final report.

Event Description

Hearing performance with the device was affected towards the end of 2015.Reportedly the electrode array had slowly migrated out of the cochlea.Re-fitting was attempted.The recipient was re-implanted (b)(6)-2017.Also, the user has no longer residual hearing in the low frequencies after the first implantation and so a longer electrode array was chosen for re-implantation.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 7147192
• MDR Text Key: 95790154
• Report Number: 9710014-2017-01105
• 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,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Other Device ID Number: (01) 09008737094003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 79 YR