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

Model Number S0521-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider reported that a patient had the implant removed due to alleged pain and irritation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOPHONO® IMPLANT
• Type of Device: HEARING AID, BONE CONDUCTION
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7949694
• MDR Text Key: 123190772
• Report Number: 1045254-2018-00484
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132189
• 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,Followup
• Report Date: 01/16/2019

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: S0521-02
• Device Catalogue Number: S0521-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/16/2019
• 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