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/75
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled left ventricular (lv) lead's revision procedure due to high capture thresholds.Upon opening the pocket, infection was noted, and the left side was occluded.The physician decided to remove the pulse generator and the right atrial (ra) lead.The lv lead was not able to be removed due to patient's anatomy and the patient being dependent.A new cardiac resynchronization therapy pacemakers and a new left ventricular (lv) lead were implanted.The patient had no adverse consequences.
Additional Manufacturer Narrative
The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.The results of the investigation are inconclusive since the lead was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22639834
• Report Number: 2017865-2025-96112
• Device Sequence Number: 21216933
• Product Code: OJX
• UDI-Device Identifier: 05414734502603
• UDI-Public: (01)05414734502603(10)A000134372(17)251031
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 1258T/75
• Device Lot Number: A000134372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 07/30/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 07/28/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 53 KG