MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	1258T/92
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests that the death was device or lead related.The cause of death was unknown.No additional information was reported.
Additional Manufacturer Narrative
The lead was returned due to patient deceased.As received, only the connector portion of the lead was returned in one piece.Visual examination of the lead did not find any anomalies except for procedural damage.Electrical testing was normal.
Additional Manufacturer Narrative
D6-b: date of explant should be (b)(6) 2026 in initial report.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25368363
• Report Number: 2017865-2026-11446
• Device Sequence Number: 9994731
• Product Code: OJX
• UDI-Device Identifier: 05414734502627
• UDI-Public: (01)05414734502627(10)A000112898(17)240630
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 1258T/92
• Device Lot Number: A000112898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/16/2026; 06/23/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/16/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: Death
• Patient Sex: Unknown