MAUDE Adverse Event Report: MEDTRONIC BRAVO¿ CALIBRATION-FREE REFLUX TESTING SYSTEM; BRAVO¿ REFLUX RECORDER

Model Number LBL-2302-01

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

First bravo¿ calibration-free reflux capsule was placed and verified on reflux recorder.Reflux recorder stopped working.Second bravo¿ calibration-free reflux capsule was placed and a new reflux recorder was paired and remained connected.

• Brand Name: BRAVO¿ CALIBRATION-FREE REFLUX TESTING SYSTEM
• Type of Device: BRAVO¿ REFLUX RECORDER
• Manufacturer (Section D): MEDTRONIC; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 18855735
• MDR Text Key: 337102076
• Report Number: 18855735
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LBL-2302-01
• Device Lot Number: BR30303349
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2023
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/07/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female