MAUDE Adverse Event Report: MEDTRONICS GIVEN IMAGING LTD. MEDTRONICS BRAVO CF RECORDER; ELECTRODE, PH, STOMACH

Device Problem Loss of Data (2903)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2021

Event Type  malfunction  

Event Description

Patient had a bravo device placed and the device malfunctioned.The data was corrupt and not able to be sent to the provider.Fda safety report id # (b)(4).

• Brand Name: MEDTRONICS BRAVO CF RECORDER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONICS GIVEN IMAGING LTD.
• MDR Report Key: 13659401
• MDR Text Key: 286570863
• Report Number: MW5107829
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White