MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX XL LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1158T/75

Device Problems Failure to Capture (1081); Naturally Worn (2988)

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

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the left ventricular (lv) lead had a history of externalization since 2017, and the lead had been deactivated.On (b)(6) 2021, the patient presented for routine device exchange.During the procedure, while trying to activate the lv lead; interrogation revealed, the lv lead exhibited loss of capture.Further testing showed the lead was able to capture in bipolar configuration.The lead remains implanted and is in use with the new device.The patient condition was stable before, during, and after the procedure.

Manufacturer Narrative

Correction - h7 should have been checked "recall", h9 should have "z-1483-2012" filled.

• Brand Name: QUICKFLEX XL LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11593054
• MDR Text Key: 243093288
• Report Number: 2017865-2021-12013
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): Y
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: 1158T/75
• Device Lot Number: 0002130424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1483-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR