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

Model Number MI1000 MED-EL CONCERT

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Vibration (1674); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); Burning Sensation (2146)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent a 1.5t mri of her back during which the patient experienced burning and pain.Reportedly, prior to the scan the mri center contacted the patient's audiologist and she referred them to med-el and the implanted surgeon.The patient could not tolerate imaging due to feeling of pain, vibration and electrical shock.The patient now reports that she feels vibrations with the placement of the rondo audio processor on her head with no stimulation.The patient also reports not feeling the vibration with the opus 2 audio processor but once it is turned on, she felt electrical shocks and removed it.Further testing is scheduled for (b)(6) 2015.

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.

Manufacturer Narrative

(b)(4).Conclusions: based received information, the observed symptoms were not caused by the cochlear implant but rather by a too tight headband, applied before the mri, which might have exerted pressure on the occipital nerve.Once the pain was treated by the implanting surgeon, the patient rapidly regained benefit from the device.No further problems were observed.This is a final report.

Event Description

It was reported that the patient underwent a 1.5t mri of her back during which the patient experienced burning and pain.Reportedly, prior to the scan the mri center contacted the patient's audiologist and she referred them to med-el and the implanted surgeon.The patient could not tolerate imaging due to feeling of pain, vibration and electrical shock.The patient now reports that she feels vibrations with the placement of the rondo audio processor on her head with no stimulation.The patient also reports not feeling the vibration with the opus 2 audio processor but once it is turned on, she felt electrical shocks and removed it.

• 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: 4688031
• MDR Text Key: 19644769
• Report Number: 9710014-2015-00271
• 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
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737062743 (
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• 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: 28 YR