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U.S. Department of Health and Human Services

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

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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number MI1200 SYNCHRONY
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 08/21/2020
Event Type  Injury  
Event Description

The user has been experiencing persistent pain/soreness around the implant site, which is worse when smiling or moving the muscles around the site. This problem has been happening since implantation. X-ray showed receiver stimulator was placed on bone, but the coil portion was superficial to muscle. The physician thought the device is not seated properly or under the muscle enough. The user had good sound quality and performance with the device. Per patient report, over time the position of the device had shifted inferiorly. Revision surgery took place on (b)(6) 2020. Although it was originally planned to reposition the coil into a new periosteal pocket, the device had to be explanted because the array was pulled from the cochlea, which was confirmed with x-ray. There was also concern that the implant package had additionally been damaged during the reposition attempt, therefore a new device was implanted.

 
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Brand NameMED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU
MDR Report Key10605276
MDR Text Key209129405
Report Number1066702-2020-00067
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/23/2020,09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMI1200 SYNCHRONY
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/22/2020
Event Location Hospital
Date Report TO Manufacturer09/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/30/2020 Patient Sequence Number: 1
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