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

Model Number	FGS-0634
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9317938
• Report Number: 9710107-2019-00547
• Device Sequence Number: 10923643
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/01/2019; 12/01/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/03/2019; 03/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 72