PILLCAM

Description of Event or Problem

ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED FOR DARK BLEEDING. DURING HOSPITALIZATION, THE PATIENT UNDERWENT AN ENTEROSCOPY EXAM TO VIEW THE SMALL INTESTINE USING A VIDEO CAPSULE. AFTER THE VIDEO WAS DOWNLOADED, IT WAS OBSERVED THAT THERE WAS ONLY 2 MINUTES OF VIDEO IN THE STOMACH AND THEN THE VIDEO "STARTED JUST 4 HOURS LATER". THE CAPSULE WAS ALREADY IN THE INTESTINE SLENDER. THE INITIAL SEGMENT OF THE SMALL INTESTINE WAS NOT SEEN. THE PATIENT REMAINED IN THE HOSPITAL 2 DAYS TO ENSURE THAT THE PATIENT WAS NOT BLEEDING AND ALSO TO PERFORM A NEW EXAMINATION. AS PER CUSTOMER THEY HAVE FOLLOWED THE PROCEDURES NORMALLY, HOWEVER THE DOCTOR DOES NOT REMEMBER HAVING "DELAYED THE FIRST INSTRUCTION".

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G4, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. A COMPREHENSIVE EXAMINATION COULD NOT BE PERFORMED, BECAUSE THE RETURNED SAMPLE WAS NOT RECEIVED IN A STATE THAT ALLOWED FULL FUNCTIONAL OR VISUAL ASSESSMENT. IT WAS REPORTED THAT THE VIDEO RECORDING TIME WAS SHORTER THAN EXPECTED. 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. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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.

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, AN ENTEROSCOPY EXAM WAS PERFORMED TO VIEW THE SMALL INTESTINE, WHEN THE VIDEO WAS DOWNLOADED IT WAS OBSERVED THAT THERE WAS ONLY 2 MINUTES OF VIDEO IN THE STOMACH AND THEN THE VIDEO STARTED JUST 4 HOURS LATER, THAT IS WHEN THE CAPSULE WAS ALREADY IN THE INTESTINE SLENDER. HOWEVER, THE INITIAL SEGMENT OF THE SLENDER WAS NOT SEEN. THERE WAS EXTENDED HOSPITALIZATION OF 2 DAYS DUE TO THE FAILURE OF THE STUDY TO ENSURE THAT THE PATIENT WAS NOT BLEEDING.