MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number TTS-1100

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Sore Throat (2396)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, a week post radio frequency ablation procedure, the patient was admitted to the hospital due to throat pain and dysphagia.The patient was given pain reliever and placed on liquid diet.There were no error codes flagged during the procedure.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a week post inlet patch radio frequency ablation procedure, the patient was admitted to the hospital due to throat pain and dysphagia.The patient was given pain reviler both orally and intravenously and placed on liquid diet to regulate the pain and dysphagia.The customer noted that there were no error codes flagged during the procedure.The physician was not attributing the hospitalization to the device and was confident that it was due to the procedure.The patient's throat pain and dysphagia were resolved, and the patient was discharged.

• Brand Name: BARRX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8422947
• MDR Text Key: 138893183
• Report Number: 3004904811-2019-00009
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521176621
• UDI-Public: 10884521176621
• Combination Product (y/n): N
• PMA/PMN Number: K130623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TTS-1100
• Device Catalogue Number: TTS-1100
• Device Lot Number: F2503724X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention