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

Model Number FGS-0634

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had a burn by the recorder while sleeping.The patient stated that burn ointment was applied to the burned area.The customer did not find physical or heat damage to the recorder, and the study was competed and was uploaded successfully.The recorder worked correctly during the previous procedure.There was no repeat procedure necessary.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel and the sample that arrived.One bravo capsule and one bravo delivery device were received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported bravo fail to attach to patient's esophagus.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had a burn by the recorder while sleeping.The patient stated that burn ointment was applied to the burned area.The sales representative stated that the customer did not find physical or heat damage to the recorder, and thestudy was competed and was uploaded successfully.The recorder worked correctly during the previous procedure.There was no repeat procedure necessary.

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: 9317938
• MDR Text Key: 166319884
• Report Number: 9710107-2019-00547
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2020

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: Health Professional
• Device Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 12/01/2019; 12/01/2019
• Supplement Dates FDA Received: 12/03/2019; 03/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 72