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 Codes	Failure to Capture (1081); Fracture (1260); Over-Sensing (1438); Therapy Delivered to Incorrect Body Area (1508); Impedance Problem (2950)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the patient's previous routine generator change procedure, the left ventricular (lv) lead was found to be fractured and was repaired using surgical grade adhesive.Subsequently, it was noted that the lv lead exhibited loss of capture, noise over-sensing and varying low voltage impedance.Muscle stimulation and phrenic nerve stimulation were also observed on the left side of the chest.The lv lead was explanted and replaced with a new lead on (b)(6) 2026.The patient remained in stable condition.

• 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: 24765982
• Report Number: 2017865-2026-06810
• Device Sequence Number: 9349063
• Product Code: OJX
• UDI-Device Identifier: 05414734502627
• UDI-Public: (01)05414734502627(10)4675419(17)170630
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 1258T/92
• Device Lot Number: 4675419
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male