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

Model Number FGS-0313

Device Problem Device Slipped (1584)

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

Event Date 01/08/2020

Event Type  Injury  

Event Description

Given imaging, bravo ph capsule, would not attach to the gastric lining x 3 attempts with 3 capsules all from the same lot number.The procedure was unable to be completed.Event reported to medtronic rep, (b)(6).Fda safety report id# (b)(4).

• Brand Name: BRAVO PH CAPSULE DELIVERY DEVICE
• Type of Device: ELECTRODE PH STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.
• MDR Report Key: 9581002
• MDR Text Key: 175087918
• Report Number: MW5092172
• Device Sequence Number: 3
• 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: 01/09/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 47770Q
• 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 Outcome(s): Hospitalization
• Patient Age: 34 YR