MAUDE Adverse Event Report: ST. JUDE UNKNOWN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, that during a right atrial tachycardia procedure the patient developed a pericardiai effusion that the physician felt was caused by the st.Jude quadrapolar catheter in the rv.A pericardialcentesis was performed.1200cc's were removed from the pericardial space.The patient was stabilized and transferred to the ccu for observation.Pl1-mu2g20 this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17532484
• MDR Text Key: 321139470
• Report Number: MW5139392
• Device Sequence Number: 1
• Product Code: DRF
• 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: 08/12/2014

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