MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN, LLC / GIVEN IMAGING LTD. PILLCAM DATA RECORDER; ELECTRODE, PH, STOMACH

Model Number FGS-0450

Device Problem Failure to Transmit Record (1521)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

Medtronic pill cam data recorder failed to create a video of the patient's study.Fda safety report id# (b)(4).

• Brand Name: PILLCAM DATA RECORDER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC / COVIDIEN, LLC / GIVEN IMAGING LTD.
• MDR Report Key: 11422003
• MDR Text Key: 238416309
• Report Number: MW5099811
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1