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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 Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Head Injury (1879); Pain (1994)
Event Type  Injury  
Event Description
The recipient is reportedly experiencing head pressure and sound quality issues.The recipient was prescribed steroids and antibiotics.Programming adjustments were made, however, the issue did not resolve.The recipient is presenting with pain.Device testing revealed results within normal limits.A ct scan revealed correct device position.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced a head trauma prior to symptoms.External equipment was exchanged and the recipient's issues reportedly resolved.The recipient is using the device.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 Key12193999
MDR Text Key262395417
Report Number3006556115-2021-01061
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
Report Date 06/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/01/2008
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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