MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN-BRAVO

Model Number UNKNOWN-BRAVO

Device Problem Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Pain (1994); Vomiting (2144); Sweating (2444)

Event Date 05/11/2011

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient underwent the capsule placement procedure.Upon returning home and taking a few bites of something to eat, the patient started to sweat profusely.There was a slight pain in the chest.The patient tried again three hours later; the patient sweated again and vomited.The doctor prescribed carafate syrup and lorazepam for anxiety.The following day the patient was able to eat with some pain while swallowing and the food produced a pain in the chest.The reporter stated "in the endoscopy report, the doctor reported mild esophagitis found at scj, at 38 cm.The capsule placed at 32 cm.The patient checked the monitor and it varied between 4 and 7.6 during the day.Got up in the middle of night and it was 2 something but no heartburn.Four days post procedure, the patient experienced sharp pain swallowing.Six days post procedure, the patient experienced pain swallowing in the chest; sometimes extremely sharp depending on the food.Seven days post procedure the patient experienced chest pain and went to the emergency room (er).The patient was at the er for 8 hours.The healthcare professionals ruled out heart and found the capsule in t he x-ray.The capsule was removed by the doctor.

• Brand Name: UNKNOWN-BRAVO
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8199887
• MDR Text Key: 131514148
• Report Number: 9710107-2018-01095
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN-BRAVO
• Device Catalogue Number: UNKNOWN-BRAVO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention