MAUDE Adverse Event Report: GIVEN IMAGING LTD SMARTPILL RECORDER, RFB

Model Number 50100550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reports that their patient began a (b)(6) study on (b)(6) 2016 at approx.08:45am.During the course of the day, the patient reported the ph levels were inconsistent.The patient reported only 1 bm around 11:30am.The patient reported (b)(6) 2016 that there was no activity on the black box receiver.Patient also reported experiencing upper gastric pain and extreme nausea, but no vomiting.Customer confirmed that the patient did have a kub and the capsule did pass within 3 hours of ingesting it.Physician reports the patient is doing fine, and is expected in their office for a follow up soon.

• Brand Name: SMARTPILL RECORDER, RFB
• Type of Device: SMARTPILL
• Manufacturer (Section D): GIVEN IMAGING LTD; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5772949
• MDR Text Key: 48884249
• Report Number: 9710107-2016-00297
• Device Sequence Number: 1
• Product Code: NYV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50100550
• Device Catalogue Number: 50100550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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