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

Model Number 1258T

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2013

Event Type  malfunction  

Event Description

This lead was noted on (b)(6)2013 due to lead dislodgement.Once the st.Jude lead was in place, they cut off the catheter and they could not do it one step.There was not enough lead to load it on the cutter and so they have to make small cuts until there was enough lead to hold on.During this process, the lv lead dislodged slightly and had to be pushed in further without the support of the outer catheter due to having ben pulled out from the coronary sinus.The physician was dr.(b)(6) at (b)(6)hospital.No additional information is available.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: 17537493
• MDR Text Key: 321173755
• Report Number: MW5144371
• 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: 12/17/2013

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