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

Model Number 1258T

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2010

Event Type  malfunction  

Event Description

Patient information verification and identification card, hand written note from patient states: st jude lead was out of place on (b)(6) 2010.No physician or hospital known.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: 17519976
• MDR Text Key: 321323512
• Report Number: MW5126924
• 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: 02/03/2011

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