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

Model Number 1258T

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 07/09/2012

Event Type  malfunction  

Event Description

This lv lead was implanted on (b)(6) 2011.The lead was repositioned on (b)(6) 2012 due to phrenic nerve stim on ring and high outputs on tip.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: 17529079
• MDR Text Key: 321236848
• Report Number: MW5136008
• 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: 08/10/2012

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