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

Model Number MI1000 MED-EL CONCERT

Device Problems Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hearing Loss (1882); No Information (3190)

Event Date 04/07/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery was scheduled for (b)(6) 2015.Additional info received stated that the electrode wire has extruded through the skin sealing the ear canal.The surgeon ordered a ct scan to check to the device placement, but the results are not known at this point in time.Details of the revision surgery are also not available yet.

Manufacturer Narrative

(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for evaluation.When available, a device failure analysis will be submitted as a f/u report.

Manufacturer Narrative

Conclusions according to the information received, the patient suffered from chronic otitis media (com) and reportedly underwent closure of the external ear canal (eac), which is typically indicated in order to eradicate all sources of infection in cases of com and to create a closed and sterile environment.The reported electrode extrusion in the eac was likely due to the breakdown of the thin epithelial lining of the posterior canal wall.After a revision surgery to reposition the electrode and close the ear canal, the device remains implanted and reportedly working within specification.This is a final report.

Event Description

Further information states that a revision surgery was performed to reposition the electrode and close the ear canal.

Manufacturer Narrative

(b)(4).Device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.According to the patient report the device was explanted as the active electrode array migrated out of cochlea into the ear canal where the patient inadvertantly pulled the electrode completely out of the cochlea.This is a final report.

Event Description

It was reported that a revision surgery was scheduled for (b)(6) 2015.Additional information received stated that the electrode wire had extruded through the skin sealing the ear canal.It appears that the issue of the electrode extruding through the ear canal continued after the revision surgery and the patient inadvertently pulled the electrode out of the cochlea.The device has been explanted.

• 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: 4765978
• MDR Text Key: 20749581
• Report Number: 9710014-2015-00326
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737088422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2015; 03/22/2017
• 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: 64 YR