MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XOM UNKNOWN ENDO

Model Number XOM UNKNOWN ENDO

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that the patient has infections from the suture and the screw of the repose hyoid system.The repose hyoid suspension was implanted in the patient at (b)(6) in 1999.The patient started seeing a doctor in (b)(6), in 2004.It is not known when the patient started experiencing the infections.Doctor thinks he removed the infected suture but cannot confirm.The patient¿s body is treating the screw that is in the posterior mandible also as a foreign body and it is getting chronically infected.The doctor plans on removing the screw from the patient.

Manufacturer Narrative

(b)(4).The device has not been returned, the device remains implanted in the patient.Methods: no testing methods performed.This device is used for therapeutic purposes.

Manufacturer Narrative

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

• Brand Name: XOM UNKNOWN ENDO
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: sharanya jangiti ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328183
• MDR Report Key: 4182376
• MDR Text Key: 5093587
• Report Number: 1045254-2014-00258
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2014

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: XOM UNKNOWN ENDO
• Device Catalogue Number: XOM UNKNOWN ENDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: 09/24/2014
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00054 YR
• Patient Weight: 64