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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-1500-01
Device Problem Malposition of Device (2616)
Patient Problem No Information (3190)
Event Date 11/20/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Advanced bionics considers the investigation into this reportable event as closed. The recipient has reportedly resumed device use. The recipient remains implanted. This is the final report.

 
Event Description

The recipient reportedly experienced a displaced magnet following a mri. The recipient was recommended device non-use for a week. On (b)(6) 2017, the recipient underwent magnet repositioning surgery.

 
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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 Key7141045
MDR Text Key95586572
Report Number3006556115-2017-00687
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeGB
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
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 Date01/31/2015
Device MODEL NumberCI-1500-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2013
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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