MAUDE Adverse Event Report: GIVEN IMAGING LTD. PILLCAM RECORDER, DR3

Model Number FGS-0347

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 05/13/2015

Event Type  Death  

Manufacturer Narrative

Manufacture reference number: (b)(4).The actual device used in the case was not received for investigation, however, the study was returned to medtronic for investigation.After reviewing the parameters, all four antennas worked properly, however, the short video occured due to the capsule battery failure and the black gaps in the video occurred due to the capsule signal.The patient death is unrelated to the alleged device malfunction.

Event Description

A pt swallowed a pillcam capsule which as stuck at the entrance of the stomach.The capsule was pushed into the small bowel with an endoscopic tool.It was reported that the pt died later that day.No further info was provided.

Manufacturer Narrative

Manufacture reference number: (b)(4).The actual device used in the case was not received for investigation, however, the study was returned to medtronic for investigation.After reviewing the parameters, all four antennas worked properly, however, the short video occured due to the capsule battery failure and the black gaps in the video occurred due to the capsule signal.The patient death is unrelated to the alleged device malfunction.

• Brand Name: PILLCAM RECORDER, DR3
• Type of Device: PILLCAM
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon building, p.o. box 258; new industrial park; yokneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 2 hacarmel street; new industrial park; yoqneam,, CA 20692 ; IS 20692 ; 2034925267
• MDR Report Key: 5007395
• MDR Text Key: 23252588
• Report Number: 9710107-2015-00225
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death