MAUDE Adverse Event Report: GIVEN IMAGING, INC. DIGITRAPPER; ELECTRODE, PH, STOMACH

Device Problems Unable to Obtain Readings (1516); Loss of Data (2903); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Patient returned following 24 hours of monitoring.Device only captured 45 minutes, and patient will have to have repeat procedure.Manufacturer response for digitrapper, digitrapper (per site reporter).Troubleshooting done with device.Device no longer in warranty.

• Brand Name: DIGITRAPPER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17085977
• MDR Text Key: 316772477
• Report Number: 17085977
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10950 DA
• Patient Sex: Female