FDA Adverse Event Death Summary report: N

PILLCAM SB2 CAPSULE

MDR report key: 3677043 · Received February 25, 2014

Report

Report Number: 9710107-2014-00001
Event Type: Death
Date Received: February 25, 2014
Date of Event: January 30, 2014
Report Date: February 21, 2014
Manufacturer: GIVEN IMAGING LTD.
Product Code: NEZ
PMA / PMN Number: K101250
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

GIVEN IMAGING LABELING, SUCH AS USER MANUAL INDICATE THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PATIENTS WITH KNOWN OR SUSPECTED GASTROINTESTINAL OBSTRUCTION, STRICTURES, OR FISTULAS BASED ON THE CLINICAL PICTURE OR PRE PROCEDURE TESTING AND PROFILE. DIAGNOSTIC TOOLS ARE AVAILABLE TO PHYSICIANS TO ASSESS PATIENTS BEFORE ADMINISTRATION OF THE PILLCAM SB CAPSULE INCLUDING THE AGILE PATENCY SYSTEM, CT ENTEROGRAPHY, OR MR ENTEROGRAPHY.

Description of Event or Problem · 1

THE PT HAS SEVERE ONGOING BLEEDING FROM THE GUT. GI ENDOSCOPY EXAMINATION DID NOT FIND THE CAUSE, THEREFORE VIDEO CAPSULE WAS USED TO EXAMINE THE SMALL BOWEL. THE CAPSULE BECAME IMPACTED AND THE PHYSICIAN REPORTED THAT THE PT UNDERWENT SURGERY FOLLOWING THE PHILLCAM CAPSULE RETENTION AND THE PT DIED APPARENTLY DUE TO INFECTIOUS COMPLICATIONS FOLLOWING THE SURGERY, LIKELY DUE TO SEPSIS. THE PT MAY HAVE HAD UNDERLYING SIGNIFICANT INTESTINAL DISEASE BUT RESULT S OF FURTHER INVESTIGATIONS ARE BELIEVED TO BE FORTHCOMING. THE CAPSULE FUNCTIONED NORMALLY AND WAS BELIEVED TO BE INTACT WHEN FOUND IN THE TERMINAL ILEUM AT SURGERY. THE CAPSULE IS BELIEVED TO HAVE IDENTIFIED THE SITE OF BLEEDING FOR WHICH THE PT WAS REFERRED FOR CAPSULE ENDOSCOPY ORIGINALLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
114893	PILLCAM SB2 CAPSULE	PILLCAM SB CAPSULE	NEZ	GIVEN IMAGING LTD.	PILLCAM SB2 CAPSULE	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death