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
• UDI-Device Identifier: 00643169644588
• UDI-Public: 00643169644588
• 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: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/03/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR