• 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 HIRES 90K¿ 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 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-02H
Device Problems Electrode (451); Defective Component (2292)
Patient Problem No Code Available (3191)
Event Date 09/13/2018
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing open electrodes and poor performance. Revision surgery is scheduled.

 
Manufacturer Narrative

The recipient's device was reportedly explanted.

 
Manufacturer Narrative

The recipient was reportedly reimplanted with another advanced bionics cochlear device.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHIRES 90K¿ IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
delilah garcia
28515 westinghouse place
valencia, CA 91355
MDR Report Key7798839
MDR Text Key117847303
Report Number3006556115-2018-00383
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
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,Followup
Report Date 07/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2017
Device MODEL NumberCI-1400-02H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/20/2019
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 Manufactured03/12/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-