• 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-1400-01
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Granuloma (1876); Unspecified Infection (1930)
Event Type  Injury  
Event Description

The recipient reportedly experienced otitis in the middle and external ear. The recipient was given an oral antibiotic treatment and the infection resolved. The recipient then began to experience no response to stimulation with the device. Programming adjustments were made, however, the issue did not resolve. On (b)(6) 2020, the recipient underwent a middle are surgery and a granuloma near the electrode was removed. Device testing results revealed abnormal results. Revision surgery is being considered.

 
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
brooke lopez
28515 westinghouse place
valencia, CA 91355
MDR Report Key10609875
MDR Text Key209329722
Report Number3006556115-2020-01036
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeRS
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 09/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/01/2011
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/14/2009
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: 09/30/2020 Patient Sequence Number: 1
-
-