MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number	1258T/86
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lead was returned with no reported event.As received, a partial lead (only connector portion) was returned in one piece.Visual inspection found full breach insulation degradation near the connector boot.Electrical testing did not find any indication of conductor fractures or internal shorts.
Event or Problem Description
This report is to advise of an event observed during analysis.

• 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: 24702076
• Report Number: 2017865-2026-06285
• Device Sequence Number: 10439758
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: (01)05414734502610(10)4703761(17)170731
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2017
• Device Model Number: 1258T/86
• Device Lot Number: 4703761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2014
• 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
• Patient Sex: Male