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 Codes	Fracture (1260); Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left ventricular (lv) lead exhibited a high capture threshold, resulting in phrenic nerve stimulation.A fracture was also noted on the lv lead.The physician elected to explant and replace the lv lead.The patient¿s condition was not known.
Additional Manufacturer Narrative
Only a distal portion of the lead was returned in one piece for analysis.The reported events of inadequate capture and lead fracture were not confirmed.Visual inspection and x-ray examination of the lead found no anomalies with the exception of damages consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 25340947
• Report Number: 2017865-2026-11221
• Device Sequence Number: 20110878
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: (01)05414734502610(10)3500048(17)140930
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 06/09/2026

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: 09/30/2014
• Device Model Number: 1258T/86
• Device Lot Number: 3500048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURATAARECIBO.; TENDRILACTIVE.; UNIFY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 104 KG