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

Model Number	FGS-0450
Medical Device Problem Codes	Loss of Power (1475); Noise, Audible (3273)
Health Effect - Clinical Codes	Chest Pain (1776); Heartburn/Indigestion (1883)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8712779
• Report Number: 9710107-2019-00263
• Device Sequence Number: 2022115
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: 07290101363064
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/23/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR