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

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC CLARION¿ IMPLANT COCHLEAR IMPLANT

  • 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
 

ADVANCED BIONICS, LLC CLARION¿ IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number AB-5100R
Device Problems Electrode (451); Defective Component (2292); Output below Specifications (3004)
Patient Problem No Code Available (3191)
Event Date 05/17/2018
Event Type  Malfunction  
Event Description

The recipient reportedly experienced open electrodes and sound quality issues. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
Manufacturer Narrative

The recipient reportedly also experienced decreased performance.

 
Manufacturer Narrative

The external visual inspection revealed slices at the fantail region. This is believed to have occurred during revision surgery. The photographic imaging inspection noted broken electrode wires in the epoxy header region. System lock was verified. The device passed some of the electrical tests performed. The device passed the mechanical tests performed. This is the interim report.

 
Manufacturer Narrative

The external visual inspection revealed slices at the fantail region. This is believed to have occurred during revision surgery. The photographic imaging inspection noted broken electrode wires in the epoxy header region. System lock was verified. The device passed some of the electrical tests performed. The device passed the mechanical tests performed. It is believed that the failure of this device was caused by the broken electrode wires found in the epoxy header region. It is believed that these breaks caused the out of range impedance reported. This older device configuration is no longer manufactured. This is the final report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLARION¿ IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
lacey mcdonald
28515 westinghouse place
valencia, CA 91355
MDR Report Key7651558
MDR Text Key113006481
Report Number3006556115-2018-00274
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/12/1999
Device MODEL NumberAB-5100R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/27/1997
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-