UNKNOWN PILLCAM CAPSULE

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: CST-0001-01, CUSTOMER COMPUTER -TBD (SERIAL#PILLCAM) 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 WAS RETAINED FOR MORE THAN 2 MONTHS AND THE PATIENT EXPERIENCED PAIN. THE PATIENT HAD AN X-RAY 7 DAYS AFTER THE CAPSULE WAS SWALLOWED AND THE CAPSULE WAS SEEN OVER THE RIGHT LOWER QUADRANT POSSIBLY WITHIN THE CECUM. DAY AFTER THE X-RAY, THE PATIENT DRANK 1 BOTTLE OF MIRALAX WITH 64 OZ OF FLUIDS IN HOPES OF PASSING THE CAPSULE. AFTER 5 DAYS, THE PATIENT HAD ANOTHER X-RAY AND THE CAPSULE WAS SEEN WITHIN THE RIGHT UPPER QUADRANT PRESUMED WITHIN THE HEPATIC FLEXURE AND THERE WAS NON OBSTRUCTIVE BOWEL GAS PATTERN. AFTER 7 DAYS, ANOTHER X-RAY WAS PERFORMED OBSERVING THE FOLLOWING: NONOBSTRUCTIVE BOWEL GAS PATTERN, GAS AND STOOL THROUGHOUT THE COLON, NO ABNORMAL VISCERAL CALCIFICATIONS, AND THE CAPSULE PROJECTED OVER THE LEFT ABDOMEN. THE PATIENT ALSO RESTARTED DRINKING MIRALAX. ANOTHER X-RAY WAS DONE AFTER MORE THAN A WEEK. ANOTHER X-RAY OF ABDOMEN WAS DONE AFTER A MONTH AND THE CAPSULE WAS SEEN MORE RIGHT OF MIDLINE THAN THE PREVIOUS X-RAY AND COULD BE WITHIN DISTAL SMALL BOWEL, WITHIN TORTUOUS SIGMOID LOOP ECCENTRIC TO THE RIGHT. THE PATIENT WAS SCHEDULED AGAIN FOR A CT (COMPUTED TOMOGRAPHY) SCAN OF ABDOMEN AND PELVIS AFTER 2 WEEKS.