MAUDE Adverse Event Report: MEDTRONIC INC. BRAVO; ELECTRODE, PH, STOMACH

Model Number BRAVO

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

Patient came in for a bravo and capsule was placed on [redacted date].Patient returned on monday [redacted date] stating that bravo monitor kept beeping and not following commands.[redacted name] parent assessed device and it was in fact not working.Patient stated this occurred within 24hrs of placement and he has called on call md-dr.(b)(6) to help him troubleshoot but she was unable and directed him to come in on monday morning.(b)(6) called me and i suggested she pair the device with a new monitor to see if it could capture the capsule information.It did in fact work and pt was instructed to return on friday [redacted date] after 96hrs again.Initial bravo from [redacted date] was sent to manufacturer but data was unable to be retrieved.Device is out for repair.2nd bravo device did function but only captured approx 18 hours of data since capsule detached from esophagus since it had been attached for greater than 5 days at this point and it is made to begin detachment after 96 hours.Pt now no longer has useable data to assess his gerd symptoms, so endoscopy has to be repeated for bravo placement again.Device was returned to medtronic and a spare device was given to the hospital.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 18703265
• MDR Text Key: 335360891
• Report Number: 18703265
• 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: 02/02/2024

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
• Device Model Number: BRAVO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male