MAUDE Adverse Event Report: ST. JUDE BRK TRANSSEPTAL NEEDLE; TROCAR

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 02/01/2022

Event Type  Injury  

Event Description

The patient reported that their tens unit bothered their back during the trial, and that they experienced a tweaking/shocking sensation in their backside when they turned the unit on.The patient also reported that they stopped using the tens unit.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17536320
• MDR Text Key: 321146392
• Report Number: MW5143208
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1