MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Failure to Transmit Record (1521)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, they had issues with capsule transmitting and outside interference during the outpatient study.The capsule was placed at 32cm with a blue light and #1 signal reading ph 6.5 upon discharge.The patient returned shortly to the facility because of the loss of signal.They held the recorder to the chest and was able to recapture the signal.The patient called from home stating that they lost the signal again after removing the recorder from the chest and without any high frequency surroundings.The patient did not have any defibrillator, pacemaker, neurostimulator, or any other contraindicated devices.They already informed the clinical product specialist, but was unable to provide solutions based on the troubleshooting performed.They instructed the patient to return to the facility and confirmed the ability to capture the signal in the patient room and was losing it each time they were leaving the facility.They used another recorder and paired it with the placed capsule, but it also lost signal after leaving the facility.They opened another capsule that was not placed in the patient and paired it to the second recorder used and the signal was not lost upon leaving the facility and walking around outside, thus confirming that the patient had a faulty capsule.The recorder worked correctly during the previous procedure.There was no patient and user harm.A chest x-ray was ordered by the physician to assess if the capsule was still attached and a repeat procedure was necessary after confirmation of the removal of the existing capsule outside the patient's body.

Manufacturer Narrative

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

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• 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: 9179128
• MDR Text Key: 161944533
• Report Number: 9710107-2019-00465
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: 07290101369714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2020
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 45802F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• Date Device Manufactured: 05/06/2019
• 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): Other
• Patient Age: 53 YR