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

Lot Number 49074F

Device Problems Malposition of Device (2616); Connection Problem (2900)

Patient Problem Dyspnea (1816)

Event Date 12/01/2020

Event Type  Injury  

Event Description

We have had several malfunctioning bravo deployments.The bravo capsule is not connecting to esophagus.The rep from medtronic stated company is aware and they shut down manufacturing to resolve issue.Pt yesterday had difficulty breathing.The capsule was in the lungs.The patient was intubated and transferred to the er.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: 10945696
• MDR Text Key: 220003789
• Report Number: MW5098195
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 49074F
• 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?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR