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

Model Number FGS-0635

Device Problems Positioning Failure (1158); Failure to Transmit Record (1521); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the capsule malfunctioned.The physician suspected that the capsule was dislodged and it bounced around the stomach which created trauma and it caused pain.The capsule passed through the patient's system without recording any data.

Event Description

According to the reporter, the capsule malfunctioned.The patient had history of heartburn and acid reflux and the physician performed an esophagogastroduodenoscopy (egd) procedure.The patient had no difficulty during the procedure but stated that pain was experienced for 4 days after the placement, approximately 30 minutes after eating.The patient described the pain as ¿sharp and jagged¿ in the stomach.After 4 days, the patient called the nurse and the physician determined that the device system did not produce any readings.The patient claimed that there were no ph readings and that the physician stated it must have malfunctioned.The pain subsided after 4 days and the patient no longer experienced reflux as they adjusted their diet.The patient declined to have the procedure repeated.The physician suspected that the capsule was dislodged and it bounced around the stomach which created trauma and it caused pain.The capsule passed through the patient's system without recording any data.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Review of the medical records identified, the capsule placement was attempted three times.The last attempt was successful.The capsule attached to the esophagus.In addition, the patient had a prior history of retrosternal pain.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 10574884
• MDR Text Key: 208185438
• Report Number: 9710107-2020-00455
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/15/2021
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 49376F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/22/2020; 01/07/2021
• Supplement Dates FDA Received: 10/09/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR