UNKNOWN PILLCAM CAPSULE

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0591, FGS-0591 PILLCAM SENSOR ARRAY MS (LOT#80020S); FGS-0347, FGS-0347 PILLCAM RECORDER DR3 X1 (SERIAL#UNKNOWN). 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 MOMENTARILY GOT STUCK IN THE PATIENT'S THROAT BEFORE SWALLOWING. THEN, THE RECORDER WENT FROM BLUE TO FLASHING ORANGE THEN TURNED OFF AS SOON AS THE PATIENT SWALLOWED THE CAPSULE. THE RECORDER HAD NO ERROR MESSAGE NOR ICON INDICATORS, WAS FULLY CHARGED AND WAS AT 92% WHEN POWERED BACK ON. THE CUSTOMER UPLOADED THE VIDEO AND IT WAS ONLY A FEW MINUTES LONG. THERE WAS NO PATIENT OR USER HARM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE INVOLVED DEVICE WAS NOT RETURNED. HOWEVER, THE ELECTRONIC DEVICE-USE LOGS WERE AVAILABLE. IT WAS OBSERVED FROM THE LOGS THAT THE CAPSULE HAD NOT STARTED RECORDING AND THE FRAME RATE WAS NOT INITIATED DURING THE STUDY. THIS INDICATED A CAPSULE FAILURE. IT WAS REPORTED THAT THE VIDEO RECORDING TIME WAS SHORTER THAN EXPECTED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A CAPSULE FAILURE. IT WAS ALSO REPORTED THAT THE CAPSULE WAS DIFFICULT TO SWALLOW. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.