MAUDE Adverse Event Report: MEDTRONIC, INC. LV LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Patient Problems Failure of Implant (1924); Cardiac Tamponade (2226); Pericardial Effusion (3271); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that this patient was enrolled into a boston scientific clinical study.Prior to any boston scientific products being implanted, the patient underwent a lead extraction procedure to remove this right ventricular (rv) lead and the left ventricular (lv) lead.This procedure resulted in a cardiac tamponade, which required a patch repair via an open thoracotomy, and a blood transfusion.The patient was hospitalized for one week.Diagnostics performed include x-rays, transesophageal echocardiogram (tee) to diagnose the cardiac tamponade, and computed tomography (ct) scans for stroke concerns.A chest x-ray performed one day prior to discharge showed persistent mild edema and a trace/small right effusion.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5145691.

• Brand Name: LV LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17756756
• MDR Text Key: 323637148
• Report Number: MW5145692
• Device Sequence Number: 1
• Product Code: OJX
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: RV LEAD