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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 MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Event or Problem Description
The user's internal device has shifted since surgery, causing the external processor to no longer sit appropriately on her ear.The recipient could not wear the audio processor (sonnet 2 or rondo 3) without it now hitting the glasses and without discomfort.A revision surgery took place on (b)(6) 2021.The implant housing migrated and initially the surgeon intended to move the same device back into position.While dissecting tissue away from the lead, the array was inadvertently pulled out of the cochlea and so a new implant was used.
 
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Brand Name
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Common Device Name
COCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key12566982
Report Number1066702-2021-00080
Device Sequence Number11038053
Product Code MCM
UDI-Device Identifier09008737366810
UDI-Public(01)09008737366810
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/04/2021
Report Date (Section F) 09/23/2021
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
Operator of Device Health Professional
Device Model NumberMI1250 SYNCHRONY 2 PIN
Device Catalogue Number36710
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/23/2021
Event Location Hospital
Date Report to Manufacturer09/23/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
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