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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled generator exchange procedure.During the procedure, the right atrial (ra) and left ventricular (lv) leads were visually observed to have insulation breaches.The leads were repaired and remain in use.The patient was reported to be 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: 25453437
• Report Number: 2017865-2026-12047
• Device Sequence Number: 12942928
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: (01)05414734502610(10)4480240(17)170228
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 06/12/2026

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: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 1258T/86
• Device Lot Number: 4480240
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2088TC/58 TENDRIL LEAD; CDHFA500D GALLANT ICD; LDA210Q/58 OPTISURE LEAD; PM3222 ALLURE PACEMAKER
• Patient Age: 76 YR
• Patient Sex: Male