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

Model Number 1258T

Device Problems Impedance Problem (2950); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This lv lead was implanted on (b)(6) 2013, and remains implanted at the time.A call was placed to technical services on 08/22/2016 , stating that there was a polarity switch, more that 2000 ohms back in april.The lv lead thresholds was high.Continued to watch.Intrinsic lv out of range.The physician was dr.(b)(6), at (b)(6).No other 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: 17535268
• MDR Text Key: 321403222
• Report Number: MW5142167
• 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: 01/13/2017

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