FDA Adverse Event Death Summary report: N

PILLCAM SB2L

MDR report key: 1113503 · Received August 13, 2008

Report

Report Number: 9710107-2008-00002
Event Type: Death
Date Received: August 13, 2008
Date of Event: August 1, 2008
Report Date: August 10, 2008
Manufacturer: GIVEN IMAGING LTD.
Product Code: NEZ
PMA / PMN Number: K070475
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

GIVEN IMAGING HAD BEEN INFORMED THAT THE PT DIED FROM A HEART ATTACK AND IT IS VERY MUCH LIKELY THAT THE CAPSULE IS NOT THE CAUSE FOR HIS DEATH. ACCORDING TO THE INSTITUTE OF FORENSIC MEDICINE IN DORTMUND, THE MOST PROBABLE CAUSE OF DEATH WAS AN ACUTE SEPTAL MYOCARDIAL INFARCT. THE PT SUFFERED FROM CORONARY ARTERY DISEASE AND ALREADY HAD UNDERGONE TWO STENT PLACEMENTS. ON THE DAY OF THE CAPSULE ENDOSCOPY, THE PT DID NOT SHOW ANY SYMPTOMS. HE HAD NO DIFFICULTY IN BREATHING. PRODUCT ASSOCIATED MARKETING DOCUMENTS, SUCH AS USER MANUAL, WHICH ARE DISTRIBUTED TO ALL OUR CUSTOMERS, INDICATE A CONTRAINDICATION FOR USE IN PTS WITH SWALLOWING DISORDERS. THE PT HAD A CONDITION THAT IS KNOWN TO BE A CONTRAINDICATION TO CAPSULE ENDOSCOPY. SINCE THE PT HAS ASPIRATED THE CAPSULE, IT APPEARS THAT HE HAD HAD A SWALLOWING DISORDER.

Description of Event or Problem · 1

THIS EVENT OCCURRED IN OTHER COUNTRY TO A PT. INITIALLY, THE PT SWALLOWED THE CAPSULE BUT THEN COUGHED IT OUT. THE PT THEN SWALLOWED THE CAPSULE A SECOND TIME. THE PT APPEARED WELL AND THERE WAS NO INDICATION THAT HE HAD ASPIRATED THE CAPSULE. CONSEQUENTLY, HE WAS SENT HOME. LATER THE SAME DAY, THE WIFE OF THE PT CALLED THE EMERGENCY SERVICES. PT DIED AFTER UNSUCCESSFUL RESUSCITATION BY EMERGENCY PHYSICIAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PILLCAM SB2L	PILLCAM SB2L	NEZ	GIVEN IMAGING LTD.	SB2L	6207S2L

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Death