• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number MI1250 SYNCHRONY 2
Device Problems Improper or Incorrect Procedure or Method (2017); Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 09/07/2022
Event Type  malfunction  
Event Description
The user had an accident and the hearing performance with the device is affected.The user was explanted.
 
Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Manufacturer Narrative
Conclusion: according to the information received from the field the electrode array was accidentally pulled out of cochlea by the recipient.Device investigation revealed damage to the active electrode due to device minute mobility, possibly following the unintentional active electrode misplacement.Reportedly the recipient is handicapped and was manipulating the device in the middle ear with a sharp instrument, which might have contributed to the observed damages.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
 
Event Description
The user had an accident and the hearing performance with the device is affected.As per additional information, it is thought that the user opened the sutured auditory canal and penetrated a sharp object into the middle ear.When the object was further extended the entire electrode was pulled out of the cochlea through the skin suture into the external auditory canal.It is thought that this happened somewhere between the (b)(6) 2022 and the (b)(6) 2022.The device was explanted.The user won't be re-implanted, as further automanipulative behavior cannot be excluded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15410718
MDR Text Key300319157
Report Number9710014-2022-00672
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737395438
UDI-Public(01)09008737395438
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 01/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/08/2023
Device Model NumberMI1250 SYNCHRONY 2
Device Catalogue Number39571
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/08/2022
Initial Date FDA Received09/13/2022
Supplement Dates Manufacturer Received09/08/2022
Supplement Dates FDA Received01/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2020
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 Age19 YR
Patient SexMale
-
-