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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 Extrusion (2934)
Patient Problem Skin Tears (2516)
Event Date 11/29/2017
Event Type  Injury  
Event Description

The recipient is reportedly experiencing a skin flap breakdown at the implant site and device extrusion. On (b)(6) 2017 the recipient was hospitalized. On (b)(6) 2017, the recipient's device was explanted. Revision surgery will be scheduled when the issue is resolved.

 
Manufacturer Narrative

The recipient is reportedly doing well.

 
Manufacturer Narrative

(b)(4). 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 revealed damaged antenna wires. This is not believed to be related to the return reason. System lock was verified. The electrode condition prevented an electrical test from being performed. The device passed the electrical and mechanical tests performed. This device was explanted for medical reasons. The device passed the tests performed. This is the final report.

 
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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 Key7141041
MDR Text Key95586419
Report Number3006556115-2017-00686
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup,Followup
Report Date 11/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/27/2017
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 Manufactured06/17/2011
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: 12/21/2017 Patient Sequence Number: 1
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