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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-04
Device Problem Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative

Udi number: ni.

 
Event Description

The recipient reportedly had a partial insertion of the electrode array during implant surgery. Revision surgery is scheduled.

 
Manufacturer Narrative

(b)(4). The recipient reportedly experienced a medical emergency during revision surgery. The recipient's medical emergency was reportedly not device related. The recipient had mastoiditis. The recipient's device was explanted. The recipient will not be reimplanted.

 
Manufacturer Narrative

(b)(4). The recipient is reportedly doing well. 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 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¿ ADVANTAGE 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 Key7142758
MDR Text Key95637977
Report Number3006556115-2017-00695
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
Report Date 11/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2018
Device MODEL NumberCI-1500-04
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/05/2018
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 Manufactured07/20/2016
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: 12/22/2017 Patient Sequence Number: 1
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