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

Model Number 14S8Q

Device Problems Over-Sensing (1438); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that his left ventricular (lv) lead exhibited oversenslng due to lead placement lv issues lvpp and doesn't pace when oversees the signal only rv paces lead to pacing inhibition.The patient underwent additional testing and the physician noted that the over detection occurred during there respiratory movements of the sternum.At this time, the lead remains in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEFT VENTRICULAR LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17523894
• MDR Text Key: 321244082
• Report Number: MW5130842
• 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: 11/02/2020

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: 14S8Q
• Patient Sequence Number: 1