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

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¿.

• Brand Name: SOPHONO® PROCESSOR
• Type of Device: HEARING 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 Key: 6999058
• MDR Text Key: 90961236
• Report Number: 1045254-2017-00394
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K153391
• Number of Events Reported: 1
• 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 Received: 11/03/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: S0415-02
• Device Catalogue Number: S0415-02
• 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 Received: 10/05/2017
• 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