MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM SMARTPILL; GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE

Model Number 50100100

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

Patient Problems Abdominal Pain (1685); Vomiting (2144); Radiation Exposure, Unintended (3164)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the customer called in to report the patient was experiencing pain the day after ingesting a smartpill capsule.The patient reported on a scale from 1-10 their pain was at a 8.The pain resided in the upper right abdominal and below the flank area of the lower back.Medtronic medical affairs followed-up with the customer and was told the patient had vomited twice.The patient went to the emergency room and spoke with triage, the patient subsequently went home.The customer followed-up with the patient the next day and was told the patient went back to the emergency room after the initially visit.They had a temperature of 102.On (b)(6) 2017 the patient passed the smartpill capsule at approximately 9:30am.The patient underwent a ct scan which showed a kidney abscess.The customer reported the pain and fever the patient experienced was associated with the kidney abscess.The patient will be referred to a specialist.

• Brand Name: SMARTPILL
• Type of Device: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925297
• MDR Report Key: 6987422
• MDR Text Key: 90762259
• Report Number: 9710107-2017-05585
• 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: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50100100
• Device Catalogue Number: 50100100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 28 YR