• 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-1600-05
Device Problems Output below Specifications (3004); Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 11/05/2020
Event Type  Injury  
Event Description

The recipient reportedly experienced electrode migration and decreased performance. Programming adjustments were made, however, the issue did not resolve. 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 Key10869567
MDR Text Key217160044
Report Number3006556115-2020-01302
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI-1600-05
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/22/2018
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: 11/19/2020 Patient Sequence Number: 1
-
-