• 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-1400-02H
Device Problem Program or Algorithm Execution Problem (4033)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2019
Event Type  malfunction  
Event Description
The recipient is reportedly experiencing an abnormal electrode.Programming adjustments and deactivation of some electrodes were performed, however, the issues did not resolve.Revision surgery will be scheduled.
 
Manufacturer Narrative
The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
Manufacturer Narrative
The external visual inspection revealed silicone damage on the top cover, a slice on the fantail, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the fantail.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode confirmed fatigue breaks at the fantail.The photographic imaging inspection revealed broken wires in the fantail region.It is believed that these breaks caused the open circuits reported.A corrective action was implemented.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
Event Description
The recipient is reportedly experiencing open electrodes.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 Name
HIRES 90K¿ IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key8287397
MDR Text Key134567740
Report Number3006556115-2019-00012
Device Sequence Number1
Product Code MCM
UDI-Device Identifier07630016816260
UDI-Public(01)07630016816260(11)150625(17)170630
Combination Product (y/n)N
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/30/2017
Device Model NumberCI-1400-02H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/29/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received04/08/2019
04/30/2019
05/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age8 YR
-
-