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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 Problems Migration or Expulsion of Device (1395); Extrusion (2934)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
Event Type  Injury  
Manufacturer Narrative

Udi number: na.

 
Event Description

The recipient reportedly experienced device extrusion and a displaced magnet. The recipient was recommended device non-use. Revision surgery is under consideration.

 
Manufacturer Narrative

The external visual inspection revealed the electrode was cut prior to receipt. This is believed to have occurred during revision surgery. The photographic imaging inspection confirmed cut electrode wires. This is believed to have occurred during revision surgery. System lock was verified. The electrode condition prevented an electrical test from being performed. The device passed the electrical tests performed. The device failed the residual gas analysis test limit. This device was explanted for medical reasons. The device passed the electrical tests performed. However, this device had moisture that exceeded the residual gas analysis test limit. The source of the problem was a feedthru hermeticity issue from one feedthru vendor. A corrective action was implemented. Feedthru assemblies from this vendor are no longer used. This is the final report.

 
Manufacturer Narrative

The recipient reportedly experienced skin breakdown. The recipient's device was explanted. The recipient will be reimplanted at a later date. The explanted magnet was discarded and will not be returned to advanced bionics for analysis.

 
Manufacturer Narrative

The recipient is reportedly healing well.

 
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Brand NameHIRES 90K¿ IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
lacey mcdonald
28515 westinghouse place
valencia, CA 91355
6613621741
MDR Report Key7152348
MDR Text Key95969172
Report Number3006556115-2017-00732
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup,Followup,Followup
Report Date 12/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2007
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/08/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/28/2017 Patient Sequence Number: 1
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