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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. SOPHONO® PROCESSOR HEARING AID, BONE CONDUCTION

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MEDTRONIC XOMED INC. SOPHONO® PROCESSOR HEARING AID, BONE CONDUCTION Back to Search Results
Model Number S0415-02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erosion (1750); Erythema (1840)
Event Date 12/04/2015
Event Type  Injury  
Manufacturer Narrative

Product evaluation: analysis results are not available; device not returned for evaluation. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The physician reported that approximately 3 months post-implantation of the sophono device, the patient presented with "erythema on magnet site; incision red and irritated and spontaneously bleeding. " the site was treated with augmentin, and the issue resolved within 1 month; (b)(6) 2016. Per the investigator, the relatedness of this event to the procedure and the sophono system is ¿possible¿.

 
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Brand NameSOPHONO® PROCESSOR
Type of DeviceHEARING AID, BONE CONDUCTION
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr north
jacksonville FL 32216
Manufacturer Contact
angie demo
6743 southpoint drive north
jacksonville, FL 32216
9043328355
MDR Report Key6999058
MDR Text Key90961236
Report Number1045254-2017-00394
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK153391
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberS0415-02
Device Catalogue NumberS0415-02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated By Manufacturer? No
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: 11/03/2017 Patient Sequence Number: 1
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