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

Model Number 1258T

Device Problems Failure to Sense (1559); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during a device changeout procedure, this left ventricular (lv) lead tested fine, pre-operatively.Once connected to the new can, there was no pacing or sensing on the lv electrogram (egm); the egm was flat without markers.This lv lead was reconnected to the old can for testing, and again there was no pacing or sensing.This lv lead was then connected to the psa with similar results: no pacing or sensing.The lv configuration in the new can was able to achieve some sensing but no capture once reprogrammed ring to right ventride (rv).It was suspected that this lv lead had changed in some way.The implant status of this lv lead was unclear, however it was noted that the physician was attempting to implant a new lead.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: QUICKFLEX MICRO LV LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17489631
• MDR Text Key: 320721364
• Report Number: MW5122162
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1258T
• Patient Sequence Number: 1