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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC HIRES 90K¿ IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-02H
Device Problems Device Unsafe to Use in Environment (2918); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient did not undergo further medical treatment.The recipient reportedly resumed device use and is doing well.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 reportedly experienced magnet displacement following an mri.The recipient's magnet was replaced during an office procedure.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The magnet was reportedly not replaced.The skin over the magnet site was opened and the same magnet was put back into place.Additional details regarding treatment will not be provided.This is the final report.
 
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Brand Name
HIRES 90K¿ IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key8740960
MDR Text Key149403837
Report Number3006556115-2019-00353
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/01/2009
Device Model NumberCI-1400-02H
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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