PILLCAM

Additional Manufacturer Narrative

TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE CUSTOMER CALLED TO INQUIRE WHETHER A DEPLOYMENT DEVICE COULD BE USED FOR A PATENCY PROCEDURE. AFTER FURTHER INVESTIGATION, IT WAS DOCUMENTED THAT THE PATIENT HAD A RETAINED PATENCY CAPSULE IN THE ANTRUM OF THE STOMACH. THE RETAINED CAPSULE WAS DISCOVERED AFTER A CT ON (B)(6) 2017. MEDTRONIC MEDICAL AFFAIRS FOLLOWED-UP WITH THE CUSTOMER REGARDING THE RETAINED CAPSULE. THE CUSTOMER REPORTED THE PHYSICIAN WAS CONTEMPLATING REPEATING THE PATENCY PROCEDURE AND POTENTIALLY PLACING THE PATENCY CAPSULE DIRECTLY IN THE PATIENTS SMALL BOWEL. PLACEMENT WOULD BE COMPLETED BY USING THE CAPSULE ENDOSCOPIC DELIVERY SYSTEM. THE CUSTOMER WAS CONCERNED THAT THE RETAINED CAPSULE MAY BE PUNCTURED BY THE REPEAT PROCEDURE. IT WAS ALSO CONSIDERED HAVING THE PATIENT INGEST THE CAPSULE AND USE A ROTH NET TO ADVANCE IT. THE PATIENT'S DIAGNOSIS WAS BLOATING AND ABDOMINAL DISTENTION. MEDTRONIC MEDICAL AFFAIRS REFERRED THE CUSTOMER FOR USE AND CONTRADICTIONS IN THE USER MANUALS. THE FEMALE PATIENT IS IN HER (B)(6), SHE IS RECEIVING TPN, IS DIABETIC, POST KIDNEY TRANSPLANT, HAS GASTROPARESIS, CONSTIPATION, HAD A GASTRIC STIMULATOR (WHICH WAS REMOVED) AND IN (B)(6) 2016 WAS DIAGNOSED WITH 3 SMALL BOWEL OBSTRUCTIONS. . THE PATIENT UNDERWENT A SMALL BOWEL RESECTION AND THE BOWEL WAS REPORTEDLY NECROTIC. THE CUSTOMER REPORTED THE PATIENT WAS TAKING "A BOAT LOAD OF MEDS". IT WAS DISCUSSED THAT PER THE PATIENT¿S HISTORY SHE IS AT RISK FOR STRICTURES A CONTRAINDICATION. TECHNICAL SUPPORT SPOKE WITH MEDTRONIC MEDICAL AFFAIRS, IT WAS SUGGESTED THAT PERHAPS THE PATIENT WOULD SIMPLY SWALLOW THE PATENCY CAPSULE IF A REPEAT PROCEDURE WAS PERFORMED.