MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0312

Device Problem Failure to Transmit Record (1521)

Patient Problems Chest Pain (1776); Pyrosis/Heartburn (1883)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient complained that the receiver beeped when he experienced two occasions of chest pain immediately after drinking cold water and regurgitation that caused prompt throat irritation.During exercise, the heartburn was very noticeable with a mild throat irritation.Also, the patient noted that the recorder turned off.The transmission of the capsule to the receiver was weakened or paused when the patient marked the symptoms.There was no intervention required because of the issue and no repeat procedure.A lubricant was used to facilitate capsule placement.The recorder worked correctly during the previous procedure.There was no patient injury.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by post market vigilance investigation personnel.The product sample was not returned to the medtronic laboratory; however, a pdf files was provided by the customer for analysis.The customer reported the patient complained that the receiver beeped when he experienced two occasions of chest pain immediately after drinking cold water and regurgitation that caused prompt throat irritation.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Based on the information provided, it is impossible to investigate.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8712781
• MDR Text Key: 148440767
• Report Number: 9710107-2019-00262
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2020
• Device Model Number: FGS-0312
• Device Catalogue Number: FGS-0312
• Device Lot Number: 44886Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2019
• 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 Age: 24 YR