MAUDE Adverse Event Report: MEDTRONIC, INC. / COVIDIEN BRAVO CF CAPSULE; ELECTRODE, PH, STOMACH

Lot Number 52091F

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

Bravo capsule was not secured in the esophagus.It had detached.Had to be retrieved from the stomach.

• Brand Name: BRAVO CF CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC, INC. / COVIDIEN
• MDR Report Key: 11574609
• MDR Text Key: 242826669
• Report Number: MW5100295
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Lot Number: 52091F
• 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: 51 YR
• Patient Weight: 58