BRAVO
Received May 27, 2026 · Event occurred Apr 28, 2026
Report 9710107-2026-00251 · MDR key 25302518
Device
Generic name
Electrode, Ph, Stomach
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0635Catalog number
FGS-0635
Lot number
68245F
Product problems
- Separation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, G3 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT¿S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE. NO LUBRICATION WAS USED TO FACILITATE CAPSULE PLACEMENT. THERE WAS NO PATIENT OR USER HARM.