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

Model Number UNKNOWN BRAVO

Device Problems Signal Artifact/Noise (1036); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

Title internal consistencies of modern reflux monitoring methods: ph-impedance monitoring vs bravo ph monitoring.Source ismail miah.Guy¿s and st thomas¿ nhs trust, greater london, uk.10.1136/gutjnl-2019-bsgabstracts.412.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source study performed in the year 2018, the study addressed the recording consistencies of the multi-channel ph-impedance technique (mii-ph) and the wireless ph method (wb-ph).The patients who had 2 days of reflux monitoring used either the mii-ph or wb-ph procedures.The consistency of normal and pathological reflux were compared between both days.The total number of patients selected for this study was 459 (91 for mii-ph and 368 for wb-ph.All patients who undergone the mii-ph method successfully completed the 48 hours recording, whereas, 24 out of 368 patients who undergone the wb-ph study encountered technical faults (capsule detachment sooner or significant artifacts captured), thus requiring to repeat the wb-ph study.The mii-ph monitoring technique seemed to offer stronger reliability of diagnosis between 2 consecutive days of recording and seemed to be less prone to technical difficulties.There was no reported patient outcome.

• Brand Name: UNKNOWN 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: 9340888
• MDR Text Key: 167015156
• Report Number: 9710107-2019-00564
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN BRAVO
• Device Catalogue Number: UNKNOWN BRAVO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2019
• 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