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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
Device Problem Microbial Contamination of Device (2303)
Patient Problem Post Operative Wound Infection (2446)
Event Date 03/08/2024
Event Type  Injury  
Event Description
The recipient experienced infection around the implant after failure of repeated antibiotic therapy and aseptic necrosis at the implant site.During the surgery they did an mastoid mucosa sample for analysis.Reportedly, the infection has been confirmed but culture results have not been made available.The device was explanted.
 
Manufacturer Narrative
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
The recipient experienced infection around the implant after failure of repeated antibiotic therapy and aseptic necrosis at the implant site.During the surgery they did an mastoid mucosa sample for analysis.Reportedly, the infection has been confirmed but culture results have not been made available.The device was explanted.
 
Manufacturer Narrative
Additional information: according to the information received from the field the concerned device was explanted due to an infection and necrosis in the post-operative period.A review of the devices sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of reported issue.However, the presence of the device might have contributed to its subsequent development.The explanted device has not been received for investigation yet.
 
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Brand Name
SYNCHRONY
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 Key18977559
MDR Text Key338563350
Report Number9710014-2024-00281
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737395452
UDI-Public(01)09008737395452
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMI1250 SYNCHRONY 2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2024
Date Device Manufactured11/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age27 MO
Patient SexFemale
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