PILLCAM

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 PATENCY CAPSULE WAS RETAINED. WHEN THE CAPSULE WAS GIVEN THE CUSTOMER RETURNED A MONTH AFTER AND COMPLAINED OF ABDOMINAL PAIN. THEY CARRIED OUT AN X-RAY AND COMPUTED TOMOGRAPHY SCAN (CT-SCAN) WHICH SHOWED CAPSULE WAS STILL IN SITE, THEY CARRIED OUT ANOTHER X-RAY AND IT SHOWED THE SAME THING THAT THE CAPSULE WAS INTACT IN THE SITE.

Additional Manufacturer Narrative

THIS REPORT IS BASED ON INFORMATION PROVIDED BY MEDTRONIC INVESTIGATION PERSONNEL. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MEDTRONIC LABORATORY; HOWEVER, AN X-RAY WAS PROVIDED BY THE CUSTOMER FOR ANALYSIS. A REVIEW OF THE PRODUCT EXPIRATION DATE DISCOVERED THIS PRODUCT WAS USED BEFORE THE EXPIRATION DATE. THE SAMPLE DID NOT MEET SPECIFICATION AS RECEIVED BY MEDTRONIC. THE X-RAY SHOW RETENTION OF PATENCY CAPSULE. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE PHYSIOLOGICAL PROBLEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED. WHEN THE CAPSULE WAS GIVEN THE CUSTOMER RETURNED A MONTH AFTER AND COMPLAINED OF ABDOMINAL PAIN. THEY CARRIED OUT AN X-RAY AND CT SCAN WHICH SHOWED CAPSULE WAS STILL IN SITE, THEY CARRIED OUT ANOTHER X-RAY AND IT SHOWED THE SAME THING THAT THE CAPSULE WAS INTACT IN THE SITE. THE CAPSULE WAS EXTRACTED BY THE PATIENT AFTER 8 DAYS WITH NO NECESSARY MEDICAL INTERVENTION.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PATENCY CAPSULE WAS RETAINED. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE LABORATORY; HOWEVER, AN X-RAY WAS PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE PHYSIOLOGICAL PROBLEM. A REVIEW OF DEVICE HISTORY RECORDS INDICATED THAT THE PRODUCT RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED. THE PATIENT HAS A HISTORY OF CROHN¿S DISEASE AND HAD SOME ABDOMINAL PAIN BEFORE THE TEST. A DAY AFTER THE CAPSULE WAS GIVEN, THE PATIENT RETURNED AND COMPLAINED OF ABDOMINAL PAIN. THE PATIENT WAS ADMITTED, AND AN X-RAY AND CT SCAN WERE PERFORMED WHICH SHOWED THAT THE PATENCY CAPSULE WAS STILL IN THE SMALL BOWEL. THE PATIENT HAD ANOTHER X-RAY 5 DAYS POST INGESTION AND THE CAPSULE WAS STILL SEEN AND INTACT. THE CAPSULE WAS EXCRETED 8 DAYS AFTER THE CAPSULE INGESTION WITHOUT A NEED FOR MEDICAL INTERVENTION.