• 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 Problems Device Operates Differently Than Expected (2913); Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 12/20/2017
Event Type  Injury  
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

The patient suffers from inconsistent responses to sound. No trauma has been reported, no redness, swelling or pain could be observed.

 
Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely. However to determine an exact root cause a device investigation of the explanted device is necessary. Re-implantation is being considered, but no surgery date has been communicated.

 
Event Description

The recipient has inconsistent responses to sound. No trauma has been reported; no redness, swelling or pain could be observed. Re-implantation is being considered but a date for surgery has not been scheduled.

 
Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely. However to determine an exact root cause a device investigation of the explanted device is necessary. The device was explanted, but has not been received for investigation yet.

 
Event Description

The recipient has inconsistent responses to sound. No trauma has been reported; no redness, swelling or pain could be observed. The user has been re-implanted.

 
Manufacturer Narrative

Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure. The problems given in the recipient report appear to match the damage found. This is a final report.

 
Event Description

The recipient has inconsistent responses to sound. No trauma has been reported; no redness, swelling or pain could be observed. The user has been re-implanted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU
Manufacturer Contact
laura simonotti
fuerstenweg 77a
innsbruck 6020
AU   6020
57788
MDR Report Key7153783
MDR Text Key96023014
Report Number9710014-2017-001121
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSONATA
OTHER Device ID Number(01) 09008737049119
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/26/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/29/2017 Patient Sequence Number: 1
-
-