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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-1400-01
Device Problem Crack (1135)
Patient Problem Irritation (1941)
Event Type  Injury  
Event Description
The recipient reportedly is reportedly experiencing a small opening at the magnet site caused by irritation.The recipient was reportedly prescribed two rounds of antibiotics.The recipient has discontinued device use.Skin flap revision surgery is under consideration.
 
Manufacturer Narrative
The recipient is reportedly still experiencing a small opening on the skin, however, there is no infection.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient's medical issue has resolved and healed.The recipient resumed device use.Additional treatment details will not be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
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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 Key10001078
MDR Text Key189580583
Report Number3006556115-2020-00299
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 user facility
Type of Report Initial,Followup,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/28/2014
Device Model NumberCI-1400-01
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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