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

Model Number 1258T/86

Device Problems Therapy Delivered to Incorrect Body Area (1508); Failure to Advance (2524)

Patient Problem Discomfort (2330)

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that during a new implant, testing parameters showed diaphragmatic stimulation by the left ventricular (lv) lead.An attempt to position the lv lead in another vessel resulted in failure to advance the guidewire into the lv lead.The lv lead could not be properly implanted.The lv lead was exchanged.The patient was stable.

Manufacturer Narrative

The reported events were cardiac stimulation and the guidewire failure to advance through the lead.As received, a complete lead without the guidewire was returned in one piece for analysis.The reported event of the guidewire failure to advance through the lead was confirmed.Visual inspection of the lead found no anomalies to the lead body.X-ray examination found the coil to be bunched/damaged at the connector region.The guidewire insertion test couldn¿t perform due to the damaged coil consistent with procedural damage.The s-curve hump height was measured within specifications.The cause of the reported event of the guidewire failure to advance was isolated to the coil being bunched/damaged found on the lead.

• Brand Name: QUICKFLEX MICRO 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: 18655427
• MDR Text Key: 334733673
• Report Number: 2017865-2024-03908
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1258T/86
• Device Lot Number: A000138661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• 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
• Treatment: CRTD