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

Model Number FGS-0636

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2019

Event Type  No Answer Provided  

Event Description

Issue with deployment of bravo capsule.Procedure rescheduled.

• Brand Name: BRAVO CAPSULE
• Type of Device: ELECTRODE, PH STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC. / MEDTRONIC
• MDR Report Key: 8616137
• MDR Text Key: 145486743
• Report Number: MW5086688
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/08/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: FGS-0636
• Device Lot Number: 44104F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• 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: 27 YR
• Patient Weight: 59