Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 SONATA
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Event Description
During a regular mapping appointment in (b)(6) of 2020 abnormal results were seen during in situ testing but no change in hearing performance with the device was observed.It was then reported that on (b)(6) 2020 the user suddenly no longer had benefit from the device.
 
Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
 
Event Description
During a regular mapping appointment in (b)(6) 2020 abnormal results were seen during in situ testing but no change in hearing performance with the device was observed.It was then reported that on (b)(6) 2020 the user suddenly no longer had benefit from the device.
 
Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
 
Event Description
During a regular mapping appointment in (b)(6) of 2020 abnormal results were seen during in situ testing but no change in hearing performance with the device was observed.It was then reported that on (b)(6) 2020 the user suddenly no longer had benefit from the device.The user was re-implanted.
 
Event Description
During a regular mapping appointment in june 2020 abnormal results were seen during in situ testing but no change in hearing performance with the device was observed.It was then reported that on (b)(6) 2020 the user suddenly no longer had benefit from the device.The user was re-implanted.
 
Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.The problems given in the recipient report appear to match the damage found.This is a final report.
 
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 Key10654645
MDR Text Key210595224
Report Number9710014-2020-00586
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737083618
UDI-Public(01)09008737083618
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup,Followup
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/05/2022
Device Model NumberSONATA
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/05/2019
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 Age6 YR
Patient SexMale
-
-