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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC CLARION¿ IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC CLARION¿ IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number AB-5100R
Device Problem Operating System Version or Upgrade Problem (2997)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Event Description
The recipient elected revision surgery for a technology upgrade.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual and photographic imaging inspections.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This older device configuration is not currently manufactured.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
CLARION¿ IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key9379808
MDR Text Key175199297
Report Number3006556115-2019-00716
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 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/29/2001
Device Model NumberAB-5100R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
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