• 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 COMBI 40+ 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 COMBI 40+ COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number PULSAR
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 06/30/2020
Event Type  Injury  
Event Description

The user has had very good performance with the device until recently when performance started to decrease. Recently he has been requiring higher and higher charge units to hear. Speech detection and discrimination are poor. Loudness growth and detection is poor for the high frequency electrode channels. The user has been re-implanted. This report refers to 9710014-2020-00374. For further information please refer to this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU
MDR Report Key10611397
MDR Text Key209340174
Report Number1066702-2020-00068
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/28/2020,10/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPULSAR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/28/2020
Event Location Other
Date Report TO Manufacturer09/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/01/2020 Patient Sequence Number: 1
-
-