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

Model Number 50100100

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a study graph was provided by the customer for analysis.The customer reported they had a short study.The reported condition was confirmed and was found to occur due to capsule failure.The investigation found: the study ended after 3 minutes, the capsule has stopped transmitting while the receiver continues.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, sometime within the first several hours, the recorder powered off.When the patient called the customer, they attempted to power the recorder back on, but it failed to power up.When they powered the recorder on, they performed an upload of the study, and they only received a 2 minute data.Technical support reviewed the data and it appeared that the capsule had zero voltage from the onset of the study, and the recorder's voltage has been just above 8 volts as it should be.They informed the customer that the study failed because of the capsule failure.The customer stated that there was a connection though there was an "x" on the monitor, they had the patient on live monitoring, and had pictures.The patient was also sent for x-ray to confirm the location of the capsule.Technical support responded that it was certain the capsule was emitting a signal at time the study initialized, but it was possible the capsule could "die" at any time if the battery was defective, or if it stopped transmitting, or if there wa s interference.The customer indicated there was no implanted device, but there was a "linx device".The patient passed the capsule.There was no user injury and no patient excessive body mass index or telemetry.

• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9294241
• MDR Text Key: 165570386
• Report Number: 9710107-2019-00538
• Device Sequence Number: 1
• Product Code: NYV
• UDI-Device Identifier: 04260167482712
• UDI-Public: 4260167482712
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 54