MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX LV LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number 1156T

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291)

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

Event Type  malfunction  

Manufacturer Narrative

Voluntary fda medwatch form received: mw5151638.Note: the lead's serial number and device details are unknown.

Event Description

It was reported that the system with a cardiac resynchronization therapy defibrillator (crt-d) and this left ventricular (lv) lead triggered an alert for lv automatic threshold test.It appeared that the test had not been able to be run for various days, nonetheless, when the crt-d was analyzed, it was no longer in suspension mode.The impedance values had increased several months ago, the behavior had been unstable and failure to capture was observed on the lv lead.Before the high, out of range pacing impedances the presenting electrogram appeared different and the lead was capturing.A lead fracture was suggested, and the health care professional agreed.The crt-d and this lv lead remain in service.No symptoms or adverse patient effects were reported.

• Brand Name: QUICKFLEX LV LEAD
• Type of Device: Drug eluting permanent left ventricular (lv) pacemaker electrode
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18976342
• MDR Text Key: 338593203
• Report Number: 2017865-2024-35852
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1156T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1