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 Problems Headache (1880); Failure of Implant (1924); Undesired Nerve Stimulation (1980)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

Explanted device and device explantation report were received at med-el usa.Per explantation report, there was an "unknown lack of function".Patient was re-implanted.

Manufacturer Narrative

(b)(4).Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report the device was explanted for medical reasons, namely lack of benefit most likely due to a pre-existing condition i.E.Acoustic neuroma followed by tumor treatment and possible auditory nerve damage.Further, the recipient was only perceiving facial nerve stimulation and light headache with the use of the device, which is a known postoperative side effect of ci implantation and might have been contributed by the high stimulation levels.The recipient has been re-implanted with a device from another manufacturer and reportedly has no benefit also with that device.This is a final report.

Event Description

The recipient was implanted with the ci in the ear where cyber knife treatment for acoustic neuroma was performed prior to implantation.The recipient had no auditory percept at activation or subsequently, even at incredibly high stimulation levels.Even without sound percept, facial nerve stimulation and low level temporal headaches were present when wearing the device.It was ultimately recommended to re-implant with a different device (a modiolar hugging model) as a final attempt to provide sound in that ear.However, it was warned that the new device could be unsuccessful again if his nerve has been too damaged to response to stimulation.Re-implantation occurred in (b)(6) 2017.The recipient has no benefit from the new modiolar hugging device as well.

• 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: 7147189
• MDR Text Key: 95790257
• Report Number: 9710014-2017-01103
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2018

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: MI1200 SYNCHRONY
• Other Device ID Number: (01) 09008737094041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 09/03/2018
• 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: 81 YR