PILLCAM

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0667, PILLCAM PATENCY CAPSULE FGS-0667 1-PACK (SERIAL # (B)(6), LOT#66759S); FGS-0347, FGS-0347 PILLCAM RECORDER DR3 X1 (SERIAL# (B)(6)). 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 PATIENT INGESTED THE FIRST CAPSULE AT 8:30 AM ON (B)(6) 2026. THE PATIENT INGESTED A PATENCY CAPSULE AS AN INPATIENT. ON (B)(6) 2026, A KUB X-RAY WAS PERFORMED AT 11:50 AM AND CONFIRMED THAT THE PATENCY CAPSULE HAD REACHED THE SMALL BOWEL. A CT SCAN WAS THEN PERFORMED AT 1:50 PM. THE SECOND CAPSULE WAS ADMINISTERED AT 2:40 PM. ON (B)(6) AN X-RAY WAS PERFORMED TO VERIFY PASSAGE OF THE SECOND CAPSULE; HOWEVER, TWO STRUCTURES WERE OBSERVED TOGETHER AT THE TOP OF THE COLON, APPEARING TO BE THE PATENCY CAPSULE AND THE SECOND CAPSULE. THE CUSTOMER CONFIRMED THAT THE VIDEO FROM THE PROCEDURE INVOLVING THE CAPSULE WAS SUCCESSFULLY CREATED.