MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Patient Problem Cardiac Tamponade (2226)

Event Type  Death  

Event Description

It was reported that an nrg transseptal needle was selected for use.The patient has passed away.The details are yet unknown, but cardiac tamponade occurred during a cryo case, and the patient subsequently died.The procedure was cancelled.It seems that while trying to place a non-boston scientific medtronic¿s achieve in ripv, it penetrated.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ACHIEVE
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 19172983
• MDR Text Key: 340941908
• Report Number: MW5154156
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Patient Sequence Number: 1
• Treatment: TRANSSEPTAL NEEDLE
• Patient Outcome(s): Death