• 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 ULTRA 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 ULTRA IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1600-04
Device Problem Output below Specifications (3004)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing decreased performance. Programming adjustments were made, however, the issue did not resolve. Revision surgery will be scheduled.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHIRES ULTRA IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
brooke lopez
28515 westinghouse place
valencia, CA 91355
MDR Report Key10806407
MDR Text Key216872215
Report Number3006556115-2020-01258
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2019
Device MODEL NumberCI-1600-04
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/14/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-