• 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 Problems Output below Specifications (3004); Appropriate Term/Code Not Available (3191)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 10/20/2020
Event Type  Malfunction  
Event Description

The recipient reportedly experienced decreased performance. The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
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 Key10806400
MDR Text Key216872003
Report Number3006556115-2020-01252
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
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 Date12/31/2019
Device MODEL NumberCI-1600-04
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/10/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-