PILLCAM COLON 2

Additional Manufacturer Narrative

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE RECORDER TURNED OFF DURING THE PROCEDURE. A CT SCAN WAS PERFORMED AFTER THE PROCEDURE TO CONFIRM THE CAPSULE LOCATION. THEY SUSPECTED THAT THE CAPSULE WAS DISCHARGED FIRST. THEY DOWNLOADED THE RECORDER DATA TO CONTINUE THE PROCEDURE AND TRIED TO CHECK IN AGAIN WITH THE CAPSULE INSIDE THE BODY. AN ERROR 65 WAS DISPLAYED ON THE RECORDER. AFTER THE FORCED TERMINATION AND INSERTED IN THE CRADLE AND RESTARTED THE ERROR 65 DISAPPEARED. PATIENT EVENTUALLY PASSED THE CAPSULE AND WAS ABLE TO HAVE ANOTHER SUCCESSFUL. THE RECORDER AND SENSOR ARRAY WORK CORRECTLY DURING THE PREVIOUS PROCEDURE.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE RECORDER TURNED OFF DURING THE PROCEDURE. A CT SCAN WAS PERFORMED AFTER THE PROCEDURE TO CONFIRM THE CAPSULE LOCATION. THEY SUSPECTED THAT THE CAPSULE WAS DISCHARGED FIRST. THEY DOWNLOADED THE RECORDER DATA TO CONTINUE THE PROCEDURE AND TRIED TO CHECK IN AGAIN WITH THE CAPSULE INSIDE THE BODY. AN ERROR 65 WAS DISPLAYED ON THE RECORDER. AFTER THE FORCED TERMINATION AND INSERTED IN THE CRADLE AND RESTARTED THE ERROR 65 DISAPPEARED. THE RECORDER AND SENSOR ARRAY WORK CORRECTLY DURING THE PREVIOUS PROCEDURE.