• 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 ADVANTAGE 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 ADVANTAGE IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-01
Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)
Patient Problem Pain (1994)
Event Date 08/17/2020
Event Type  Injury  
Event Description

The recipient reportedly experienced a displaced magnet during a mri. The recipient presented with pain. Proper bandaging protocol was not followed. On (b)(6) 2020, the magnet was surgically replaced with a new magnet. The recipient is in the process of healing.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHIRES 90K ADVANTAGE 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 Key10531986
MDR Text Key206861732
Report Number3006556115-2020-00947
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI-1500-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/17/2018
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: 09/14/2020 Patient Sequence Number: 1
-
-