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

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Discomfort (2330)

Event Date 05/14/2021

Event Type  Injury  

Event Description

Bravo ph monitor capsule placed on (b)(6) 2021.Capsule failed to detach and required endoscopic removal.Capsule caused mild to moderate discomfort while attached.Fda safety report id # (b)(4).

• Brand Name: BRAVO CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC / GIVEN IMAGING INC.
• MDR Report Key: 11957079
• MDR Text Key: 255077956
• Report Number: MW5101746
• Device Sequence Number: 1
• Product Code: FFT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 72