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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT Back to Search Results
Model Number MI1250 SYNCHRONY 2
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Head Injury (1879)
Date of Event 02/21/2025
Type of Reportable Event Serious Injury
Event or Problem Description
The recipient returned to center with concerns for changes in impedance.The user has been re-implanted.The electrode lead was found to have extruded through the tympanic membrane and 2 + channels were found extra-cochlear.This report refers to 9710014-2025-00015.For further information please refer to this report.
 
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Brand Name
SYNCHRONY
Common Device Name
COCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key22528422
Report Number1066702-2025-00015
Device Sequence Number7904402
Product Code MCM
UDI-Device Identifier09008737366827
UDI-Public(01)09008737366827
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2025
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/17/2025
Report Date (Section F) 06/17/2025
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 Lay User/Patient
Device Model NumberMI1250 SYNCHRONY 2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2025
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/17/2025
Event Location Other
Date Report to Manufacturer06/17/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/17/2025
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age6 YR
Patient SexFemale
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