MAUDE Adverse Event Report: ST. JUDE MEDICAL DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1258T

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Type  Injury  

Event Description

It was reported that the patient was having tricuspid regurgitation as a result of an interaction of the right ventricular (rv) lead with the tricuspid valve.The patient had a history of sinus bradycardia and intermittent heart block, so the doctor saw necessary to have a device able to pace the atrium and ventricle while avoiding the tricuspid valve.As a result, the rv lead was extracted due to this patient condition.A bipolar, left ventricular, competitive lead was implanted into the coronary sinus, but with the rv device port in an off label manner.The existing right atrial (ra) lead and the new, off label used left ventricular (lv lead were connected to a new dual chamber pacemaker.An subcutaneous implantable cardioverter defibrillator (s-icd) was also implanted in order to defibrillate.There was a successful patient outcome wit?? no adverse patient affects.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17536719
• MDR Text Key: 321134525
• Report Number: MW5143603
• Device Sequence Number: 1
• Product Code: OJX
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1258T
• Patient Sequence Number: 1