MAUDE Adverse Event Report: MEDTRONIC INC, GIVEN IMAGING INC/ COVIDIEN BRAVO CALIBRATION-FREE REFLUX CAPSULE DELIVERY DEVICE; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

During the upper endoscopy bravo placement, the monitoring device did not adhere twice.

• Brand Name: BRAVO CALIBRATION-FREE REFLUX CAPSULE DELIVERY DEVICE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC INC, GIVEN IMAGING INC/ COVIDIEN
• MDR Report Key: 10860522
• MDR Text Key: 217163810
• Report Number: MW5097951
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 49386F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 70